20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMPREHENSIVE REVERSE SHOULDER
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
JOBST forMen Casual
FDA UDI
BSN MEDICAL, INC.·00035664131210·FOR MEN CASUAL 20-30 MM HG KNEE HIGH CLOSED TOE...
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code LJS·April 19, 2019
ECO-S
FDA 510(k)
FDA Class 2
·Dental
MT ALERT INFUSION MONITOR
FDA 510(k)
FDA Class 2
·General Hospital
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 21, 2020
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 21, 2020
UNKVISTABRITEE
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code DQY·May 8, 2019
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·May 9, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 22, 2014
UNKNOWN DEPUY ASR 56 CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 7, 2024
ACCU-CHEK INFORM II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 16, 2024
STRATAFIX PDS PLUS SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·March 30, 2026
VICRYL POLYGLACTIN 910 SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 30, 2026
STRATAFIX SPIRAL MONOCRYL PLUS SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·March 30, 2026
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 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
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025