49 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD Hypodermic Syringe
FDA 510(k)
FDA Class 2
·General Hospital
SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS
FDA 510(k)
FDA Class 2
·Radiology
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
MANUAL FILL INFANT HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·October 17, 2008
REVO MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code LWP·August 11, 2011
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 2, 2013
NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POS
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·April 20, 2010
STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 4
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 19, 2021
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
ARTICULAR SURFACE WITH INSERT AND LOCKING SCREW SIZE EF 17 MM HEIGHT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 30, 2020
FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F
FDA Adverse Event
Injury
·ZIMMER ORTHOPAEDIC MFG. LTD.·Product code JWH·November 22, 2021
STEMMED TIBIAL COMPONENT PRECOAT SIZE 5
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JWH·November 22, 2021
ARTICULAR SURFACE WITH LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 20, 2020
TIBIAL COMPONENT STEMMED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 28, 2018
NEXGEN CR PROLONG ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·May 4, 2017
ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 29, 2020
NEXGEN ARTICULAR SURFACE ANTERIOR CONSTRAINED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 27, 2018
STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 3
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JWH·June 28, 2021
STEMMED TIBIAL COMPONENT PRECOAT
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JWH·April 15, 2019