12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
NEXGEN PERIPHERAL GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COMPRESSIBLE LIMB SLEEVE
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 9, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 14, 2024
NC SPRINTER RX
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code LOX·May 15, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014
ASR ACETABULAR CUPS 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011
UNK - CONSTRUCTS: NARROW LCP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 19, 2026
UNK - CONSTRUCTS: PLATE/SCREWS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 19, 2026
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