33 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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