30 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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