30 results · 24ms · Sources: EU EUDAMED, US FDA

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31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil

FDA 510(k)
FDA Class 2 ·Radiology

NA

FDA UDI
SYNTHES (U.S.A.) LP·10886982153364·5.0MM LOCKING SCREW SELF-DRILLING 80MM

SPECTRA OPTIA APHERESIS SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

GLP TRACK END

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 18, 2026

Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·March 7, 2018

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code FTL·May 8, 2013

OSS RS POLY TIBIAL BEARING 12

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KRO·September 4, 2020

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 18, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·May 20, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·June 10, 2024

GLP CENTRIFUGE MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·July 10, 2025

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 13, 2024

GLP CENTRIFUGE MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024