FDA Device Intelligence
Medical Device Explorer
Search manufacturer and model records from the FDA medical-device poller. This catalog complements the live cybersecurity alert feed with 510(k), recall, UDI, MAUDE adverse event, and classification context.
1932 Devices
87983 FDA Records
Imported 2026-10-10 20:14 UTC
| Manufacturer | Model | Category | FDA Data | Polled |
|---|---|---|---|---|
| 3DBIOCAD | TRUmill x250 | Dental |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 58
|
2026-10-10 |
| 3M HEALTH CARE | 390 | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| 3M HEALTH CARE | 390G | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| 3M HEALTH CARE | 490 | Radiology |
510(k) 1
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| 3M HEALTH CARE | 490H | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| 3M HEALTH CARE | 490M | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| 3SHAPE A/S | D2000 | Dental |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 58
|
2026-10-10 |
| 3SHAPE A/S | TRIOS | Dental |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 58
|
2026-10-10 |
| 3SHAPE A/S | TRIOS 3 | Dental |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 58
|
2026-10-10 |
| 3SHAPE A/S | TRIOS 4 | Dental |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 58
|
2026-10-10 |
| ABAXIS INC NORTH AMERICA | PICCOLO XPRESS | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | ACCELERATOR A3600 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | ALINITY I | Hematology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | ALINITY M | Hematology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | ARCHITECT C16000 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | ARCHITECT C4000 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 3
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | ARCHITECT C8000 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | ARCHITECT CI4100 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | ARCHITECT CI8200 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | ARCHITECT I1000SR | Hematology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | ARCHITECT I2000SR | Hematology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | ARCHITECT I4000SR | Hematology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | I-STAT | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 1
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | I-STAT 1 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | I-STAT DATA EXCHANGE | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | M2000 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | M2000RT | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | M2000SP | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | OPTIS INTEGRATED | Ophthalmic |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | OPTIS MOBILE | Ophthalmic |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | PRECISION PCX | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 1
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | PRECISION XCEED PRO | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 1
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | RALS | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | TDX | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 8
Class. 57
|
2026-10-10 |
| ABBOTT DIAGNOSTICS | TDX-FLX | Hematology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| ABBOTT LABORATORIES INC | ALINIQ INTEGRATED PLATFORM | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| ABBOTT LABORATORIES INC | ALINITY CI-SERIES | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT LABORATORIES INC | ALINITY PRO | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| ABBOTT LABORATORIES INC | FREESTYLE PRECISION PRO | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ABBOTT LABORATORIES INC | ID NOW | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ACCLARENT INC | TruDi Navigation System | Ophthalmic |
510(k) 0
Recall 1
UDI 0
MAUDE 10
Class. 56
|
2026-10-10 |
| ACCRIVA DIAGNOSTICS | AVOXIMETER 1000E | Chemistry |
510(k) 0
Recall 1
UDI 0
MAUDE 2
Class. 57
|
2026-10-10 |
| ACCRIVA DIAGNOSTICS | AVOXIMETER 4000 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ACCRIVA DIAGNOSTICS | HEMOCHRON SIGNATURE ELITE | General Hospital |
510(k) 1
Recall 1
UDI 0
MAUDE 10
Class. 56
|
2026-10-10 |
| ACCRIVA DIAGNOSTICS | VERIFYNOW | General Hospital |
510(k) 0
Recall 3
UDI 16
MAUDE 0
Class. 56
|
2026-10-10 |
| ACCURAY INC | CYBERKNIFE | General Hospital |
510(k) 8
Recall 10
UDI 0
MAUDE 10
Class. 56
|
2026-10-10 |
| ACCURAY INC | IDMS | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| ACCURAY INC | PRECISION | Radiology |
510(k) 0
Recall 8
UDI 0
MAUDE 1
Class. 51
|
2026-10-10 |
| ACCURAY INC | RADIXACT | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 1
Class. 56
|
2026-10-10 |
| ACCURAY INC | TomoHDA | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| ACCUTOME INC | A/B-SCAN PLUS | Ophthalmic |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| ACIST MEDICAL SYSTEMS INC | EMPOWER MR | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 1
Class. 51
|
2026-10-10 |
| ADVANCED INSTRUMENTS INC | 2020 | Chemistry |
510(k) 0
Recall 1
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ADVANCED INSTRUMENTS INC | 3320 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ADVANCED INSTRUMENTS INC | A20 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ADVANCED INSTRUMENTS INC | OSMO1 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ADVANCED INSTRUMENTS INC | OsmoPro | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ADVANCED STERILIZATION PRODUCTS | ASP ACCESS | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| AESCULAP INC | GN060 | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| AESKU SYSTEMS GMBH & CO | HELIOS | Hematology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| AESYNT INC | ACUDOSE-RX | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 2
Class. 0
|
2026-10-10 |
| AESYNT INC | MEDCAROUSEL | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| AESYNT INC | PACMED | Orthopedic |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| AESYNT INC | ROBOT-RX | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| AETHON INC | TUG | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| AGENA BIOSCIENCE INC | MASSARRAY DX | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | CR 30-X | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | CR 35-X | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | DR 400 | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | DX-D 100 | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | DX-D 400 | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | DX-M | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | DX-S | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | ENTERPRISE IMAGING | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | IMPAX CARDIOVASCULAR | Cardiovascular |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 55
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | IMPAX RADIOLOGY | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | IPLAN | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| AGFA HEALTHCARE CORP (US) | TALKSTATION | Gastroenterology and Urology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| AGILENT TECHNOLOGIES INC | 1290 INFINITY II | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| AGILENT TECHNOLOGIES INC | ULTIVO | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| AIR TECHNIQUES INC | SCANX CLASSIC | Radiology |
510(k) 0
Recall 0
UDI 1
MAUDE 1
Class. 51
|
2026-10-10 |
| AIR TECHNIQUES INC | SCANX INTRAORAL | Radiology |
510(k) 0
Recall 0
UDI 1
MAUDE 0
Class. 51
|
2026-10-10 |
| AIRSTRIP TECHNOLOGIES | Airstrip One | General Hospital |
510(k) 1
Recall 0
UDI 9
MAUDE 0
Class. 56
|
2026-10-10 |
| ALCON LABORATORIES INC | ARGOS | Ophthalmic |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| ALCON LABORATORIES INC | VERION REFERENCE UNIT | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| ALCOR SCIENTIFIC INC | ISED | General Hospital |
510(k) 0
Recall 1
UDI 2
MAUDE 0
Class. 56
|
2026-10-10 |
| ALCOR SCIENTIFIC INC | MINIISED | General Hospital |
510(k) 0
Recall 0
UDI 1
MAUDE 0
Class. 56
|
2026-10-10 |
| ALERE INC | AFINION 2 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ALERE INC | AFINION AS100 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ALERE INC | ALERE I | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ALERE INC | Triage MeterPro | Hematology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| ALTAMONT SOFTWARE | CAPTUREWARE | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| AMEREX INSTRUMENTS INC | HV-110 | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| AMERICAN DIAGNOSTIC CORP (ADC) | ADVANTAGE 6014 | Cardiovascular |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 55
|
2026-10-10 |
| AMERISOURCEBERGEN DRUG CORP | FASTFILL 54 | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| AMERISOURCEBERGEN DRUG CORP | MEDSELECT FLEX | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| AMERISOURCEBERGEN DRUG CORP | OPTIFILL OF-2 | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| AMNIS CORP | IMAGESTREAMX | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ANATOMAGE INC | INVIVO | General and Plastic Surgery |
510(k) 2
Recall 0
UDI 1
MAUDE 1
Class. 0
|
2026-10-10 |
| APOLLO ENTERPRISE IMAGING CORP | ARCC | Radiology |
510(k) 0
Recall 0
UDI 1
MAUDE 0
Class. 51
|
2026-10-10 |
| APOLLO ENTERPRISE IMAGING CORP | EPMM | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| APPLIED BIOSYSTEMS | 7500 FAST DX | Chemistry |
510(k) 1
Recall 0
UDI 0
MAUDE 1
Class. 57
|
2026-10-10 |
| APPLIED BIOSYSTEMS | QUANTSTUDIO 7 PRO | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| APPLIED SPECTRAL IMAGING INC | PATHFUSION | Pathology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 50
|
2026-10-10 |
| ARANZ MEDICAL | SILHOUETTE | General Hospital |
510(k) 1
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| ARKRAY USA INC | ADAMS A1c HA-8180V | Cardiovascular |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 55
|
2026-10-10 |
| ARKRAY USA INC | AUTION ELEVEN AE-4022 | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| ARKRAY USA INC | AUTION MAX AX-4030 | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| ARXIUM | FASTPAK 71 | Orthopedic |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ARXIUM | FASTPAK ELITE | Orthopedic |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ARXIUM | FASTPAK EXP | Orthopedic |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ARXIUM | FASTPAK TABLETOP | Orthopedic |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| ASCOM PATIENT SYSTEMS (US) | TELLIGENCE | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| ASCOM PATIENT SYSTEMS (US) | UNITE CONNECT | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| ASCOM PATIENT SYSTEMS (US) | UNITE MESSAGING SUITE | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| ASTERES INC | SCRIPTCENTER MX | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| ATIRIX MEDICAL SYSTEMS INC | QC-TRACK | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| AUDIOSCAN | AXIOM | Ear, Nose, and Throat |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| AUDIOSCAN | VERIFIT | Ear, Nose, and Throat |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| AUDIOSCAN | VERIFIT 2 | Ear, Nose, and Throat |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| AVASURE | AVASYS TELESITTER | Uncategorized |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| B BRAUN MEDICAL INC | DIALOG | Hematology |
510(k) 0
Recall 10
UDI 0
MAUDE 10
Class. 51
|
2026-10-10 |
| B BRAUN MEDICAL INC | DIALOG+ | Hematology |
510(k) 0
Recall 10
UDI 0
MAUDE 10
Class. 51
|
2026-10-10 |
| B BRAUN MEDICAL INC | PC1000 | Dental |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 58
|
2026-10-10 |
| BARCOVIEW LLC | MEDICAL QA WEB | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BARD ACCESS SYSTEMS INC | SITE-RITE 8 | General Hospital |
510(k) 0
Recall 0
UDI 25
MAUDE 6
Class. 56
|
2026-10-10 |
| BARD ACCESS SYSTEMS INC | SITE-RITE 9 | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BARD ACCESS SYSTEMS INC | SITE-RITE VISION | General Hospital |
510(k) 1
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BARD MEDICAL | IIS | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BAXTER HEALTHCARE CORP | AK 98 | Hematology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BAXTER HEALTHCARE CORP | AURORA SYSTEM 1000 | Hematology |
510(k) 1
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BAXTER HEALTHCARE CORP | BEDMASTER EX | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| BAXTER HEALTHCARE CORP | SPECTRUM IQ | Anesthesiology |
510(k) 0
Recall 0
UDI 0
MAUDE 10
Class. 52
|
2026-10-10 |
| BAYER CORP | Clinitek 50 | General Hospital |
510(k) 1
Recall 0
UDI 0
MAUDE 4
Class. 56
|
2026-10-10 |
| BAYER HEALTHCARE | CONTINUUM MR | Anesthesiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 52
|
2026-10-10 |
| BAYER HEALTHCARE | INTEGO PET | Radiology |
510(k) 0
Recall 2
UDI 0
MAUDE 1
Class. 51
|
2026-10-10 |
| BAYER HEALTHCARE | MARK 7 ARTERION | Radiology |
510(k) 0
Recall 1
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BAYER HEALTHCARE | MARK V PROVIS | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BAYER HEALTHCARE | SPECTRIS SOLARIS EP | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 1
Class. 51
|
2026-10-10 |
| BAYER HEALTHCARE | STELLANT D | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BAYER HEALTHCARE | STELLANT D DUAL FLOW | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BAYER HEALTHCARE | STELLANT D DUAL SYRINGE | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BAYER HEALTHCARE | STELLANT DUAL | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BAYER HEALTHCARE | STELLANT FLEX | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BAYER HEALTHCARE LLC | MRXPERION | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BAYER HEALTHCARE LLC | RADIMETRICS 2.X | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BAYER HEALTHCARE LLC | RADIMETRICS V3.X | Radiology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BD | 360 INFUSER | Anesthesiology |
510(k) 2
Recall 0
UDI 0
MAUDE 0
Class. 52
|
2026-10-10 |
| BD | ALARIS SYSTEMS MANAGER | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| BD | BACTEC FX | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 5
Class. 57
|
2026-10-10 |
| BD | BACTEC FX40 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| BD | BD CCE | Gastroenterology and Urology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| BD | BD KNOWLEDGE PORTAL | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BD | BD MAX | Chemistry |
510(k) 7
Recall 1
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BD | BD PYXIS LOGISTICS | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BD | Epicenter | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 0
|
2026-10-10 |
| BD | FACSCALIBUR | Chemistry |
510(k) 0
Recall 3
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BD | FACSCANTO | Chemistry |
510(k) 3
Recall 7
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BD | FACSCANTO II | Chemistry |
510(k) 2
Recall 4
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BD | FACSLYRIC | Chemistry |
510(k) 0
Recall 10
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BD | GUARDRAILS | Anesthesiology |
510(k) 0
Recall 0
UDI 0
MAUDE 1
Class. 52
|
2026-10-10 |
| BD | KIESTRA WCA | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| BD | PHOENIX | Chemistry |
510(k) 3
Recall 0
UDI 0
MAUDE 7
Class. 57
|
2026-10-10 |
| BD | Synapsys | General and Plastic Surgery |
510(k) 0
Recall 0
UDI 0
MAUDE 5
Class. 0
|
2026-10-10 |
| BD | TISSUE AND IMPLANT MODULE | Orthopedic |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| BD | Veritor Plus | Hematology |
510(k) 0
Recall 0
UDI 0
MAUDE 10
Class. 51
|
2026-10-10 |
| BECKMAN COULTER INC | 6517 | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | ACCESS 2 | Hematology |
510(k) 2
Recall 11
UDI 1
MAUDE 10
Class. 51
|
2026-10-10 |
| BECKMAN COULTER INC | AQUIOS CL | Chemistry |
510(k) 1
Recall 5
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | AU480 | Chemistry |
510(k) 0
Recall 3
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | AU5800 | Chemistry |
510(k) 1
Recall 7
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | AU680 | Chemistry |
510(k) 0
Recall 5
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | DTX 800 | Hematology |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 51
|
2026-10-10 |
| BECKMAN COULTER INC | DXC 700 AU | Chemistry |
510(k) 2
Recall 0
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | DXM 40 MICROSCAN WALKAWAY | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | DXM 96 MICROSCAN WALKAWAY | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | ICHEM 100 | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BECKMAN COULTER INC | IRICELL1500 | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BECKMAN COULTER INC | IRICELL2000 | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BECKMAN COULTER INC | IRICELL3000 | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BECKMAN COULTER INC | IRIS ICHEM VELOCITY | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 1
Class. 56
|
2026-10-10 |
| BECKMAN COULTER INC | IRIS IQ200 BODY FLUIDS | Cardiovascular |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 55
|
2026-10-10 |
| BECKMAN COULTER INC | IRIS IQ200 ELITE | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BECKMAN COULTER INC | IRIS IQ200 SELECT | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BECKMAN COULTER INC | IRIS IQ200 SPRINT | General Hospital |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 56
|
2026-10-10 |
| BECKMAN COULTER INC | LH 500 | General Hospital |
510(k) 2
Recall 10
UDI 0
MAUDE 10
Class. 56
|
2026-10-10 |
| BECKMAN COULTER INC | LH 780 | General Hospital |
510(k) 1
Recall 5
UDI 0
MAUDE 10
Class. 56
|
2026-10-10 |
| BECKMAN COULTER INC | MICROSCAN WALKAWAY PLUS | Chemistry |
510(k) 0
Recall 0
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | NAVIOS | Chemistry |
510(k) 1
Recall 1
UDI 0
MAUDE 3
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | NAVIOS EX | Chemistry |
510(k) 0
Recall 1
UDI 0
MAUDE 0
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | POWER EXPRESS | Chemistry |
510(k) 1
Recall 1
UDI 1
MAUDE 5
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | REMISOL ADVANCE | General and Plastic Surgery |
510(k) 0
Recall 2
UDI 3
MAUDE 1
Class. 0
|
2026-10-10 |
| BECKMAN COULTER INC | TQ-PREP | Chemistry |
510(k) 1
Recall 0
UDI 1
MAUDE 1
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | UNICEL DXC 600 | Chemistry |
510(k) 2
Recall 10
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | UNICEL DXC 600I | Chemistry |
510(k) 1
Recall 10
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | UNICEL DXC 660I | Chemistry |
510(k) 0
Recall 10
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | UNICEL DXC 800 | Chemistry |
510(k) 1
Recall 10
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | UNICEL DXC 880I | Chemistry |
510(k) 0
Recall 10
UDI 0
MAUDE 10
Class. 57
|
2026-10-10 |
| BECKMAN COULTER INC | UNICEL DXH 600 | General Hospital |
510(k) 0
Recall 6
UDI 0
MAUDE 2
Class. 56
|
2026-10-10 |
| BECKMAN COULTER INC | UNICEL DXH 800 | General Hospital |
510(k) 3
Recall 10
UDI 0
MAUDE 10
Class. 56
|
2026-10-10 |