15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
AGC DA2000 KN TIB BRG 71/75X14
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·August 31, 2016
BIOMET AGC V2 INTERLOK TIBIAL 22X 67MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HRY·June 16, 2017
AGC V2 INTERLOK TIB 10X 71MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code HRX·May 19, 2017
AGC V2 INTERLOK TIB 8 X 75MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 12, 2017
AGC V2 INTERLOK TIB 8 X 79MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 22, 2016
AGC REVISION KNEE TIBIAL AUGMENTATION
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·June 28, 2017
VIALOK NON-VENTED
FDA 510(k)
FDA Class 2
·General Hospital
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
FDA 510(k)
FDA Class 2
·Orthopedic
E1 RINGLOC BIPOLAR 28X51MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·June 17, 2019
FLEXICAP DISCONNECT CAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·December 13, 2010
PROGRASP (TM) FORCEPS
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·January 17, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2014
BIOMEX SHELL PC DIA48MM LN 22
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 2, 2015
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026