30 results
·
28ms
·
Sources: EU EUDAMED, US FDA
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VANGARD CR TIB BRG 10X71/75
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 4, 2026
VANGUARD CR INTERLOK FEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·December 20, 2018
E1 VNGD CR TIB BRG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·December 20, 2018
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973578·
ARTHREX DISTAL EXTREMITY PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RII INFRARED EAR THERMOMETER, MODEL: TH60N
FDA 510(k)
FDA Class 2
·General Hospital
VNGD ANT STBLZD BRG 10X71
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 15, 2017
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 3, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 3, 2013
PFC SIGMARP STB TB IN 3 10.0
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·June 22, 2011
VANGUARD CR ILOK FEM-LT 67.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·May 29, 2019
VNGD CR TIB BRG 10X71/75
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·May 29, 2019
VNGD CR TIB BRG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 2, 2023
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
VANGUARD KNEE SYSTEM PS TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 25, 2017
VANGUARD POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 8, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
VANGUARD POSTERIOR STABILIZED OPEN FEMORAL COMPONENT 65MM LEFT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 8, 2025
VNGD CR TIB BRG 10X71/75
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 27, 2023