49 results · 38ms · Sources: EU EUDAMED, 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