20 results
·
30ms
·
Sources: EU EUDAMED, US FDA
LIASYS 450
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776172046·REICH-NECHTOW HYSTERECTOMY STR FCP
JOBST forMen Casual
FDA UDI
BSN MEDICAL, INC.·00035664131319·FOR MEN CASUAL 20-30 MM HG KNEE HIGH CLOSED TOE...
General Instrument
FDA UDI
Life Spine, Inc.·00190837089320·
BIOSCREW XTRALOK
FDA 510(k)
FDA Class 2
·Orthopedic
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
FDA 510(k)
FDA Class 2
·Dental
T:FLEX INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·July 7, 2021
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 18, 2019
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 14, 2024
COBAS 6000 CORE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 16, 2008
AIR DERMATOME HANDPIECE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·May 9, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 22, 2014
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
UNK - BIOMATERIAL - CEMENT: VERTECEM V+
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·May 5, 2025
TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code MRG·April 19, 2018
AXIUM
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code HCG·December 5, 2022
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025