33 results · 26ms · Sources: EU EUDAMED, US FDA

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Prettau, ICE, Z-White zirconia blanks

FDA 510(k)
FDA Class 2 ·Dental

CoRoent

FDA UDI
Nuvasive, Inc.·00887517567666·CoRoent Ant TLIF PEEK, 8x13x30mm 4°

Vanguard® SSK Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304440289·

TEMPOSIL 2

FDA 510(k)
FDA Class 2 ·Dental

BLADDER SCANNER

FDA 510(k)
FDA Class 2 ·Radiology

MICROTEK

FDA Adverse Event
Malfunction ·MICROTEK MEDICAL, INC.·Product code KKX·May 3, 2019

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 17, 2014

AUTOPULSE? NIMH BATTERY

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION, INC·Product code DRM·June 21, 2013

ATTAIN STARFIX

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 28, 2011

V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

FDA Recall
Open, Classified ·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·November 15, 2018

V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

FDA Enforcement
Class II ·Ongoing·Vital Scientific N.V.·December 4, 2019

VNGD SSK PSC TIB BRG 18X63/67

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 14, 2017

BIOMET TIBIAL LOCKING BAR

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 23, 2018

BMT SPLINED KNEE STM V2 18X120

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 23, 2018

BIOMET TIB BLOCK 10MM 71

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 23, 2018

VNGD SSK PSC TIB BRG 18X71/75

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 23, 2018

BIOMET MODULAR TIBIAL AUGMENTATION BLOCK

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 22, 2017

BIOMET OFFSET TIBIAL TRAY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 22, 2017

BIOMET MODULAR TIBIAL AUGMENTATION BLOCK

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 22, 2017

VANGUARD DCM TIBIAL BEARING

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HRY·December 22, 2017