12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VPAP ST-A
FDA 510(k)
FDA Class 2
·Anesthesiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517564221·CoRoent Ant TLIF PEEK, 11x13x28mm 8°
DEKA SYNCHRO FT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 14, 2024
HEMOCONCENTRATOR BC 20 PLUS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code KDI·April 1, 2016
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·May 20, 2011
VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·December 29, 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