17 results
·
37ms
·
Sources: EU EUDAMED, US FDA
ANGIOSCAN (AS STAND ALONE INSTRUMENT)
FDA 510(k)
FDA Class 2
·Ophthalmic
The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
FDA 510(k)
FDA Class 2
·Orthopedic
PROBEAT-V
FDA 510(k)
FDA Class 2
·Radiology
PERFORMANCE MODULAR TIBIAL TRAY SML
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016
E1 HI-WALL LINER RINGLOC-X 60MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·January 10, 2017
PERFORMANCE FEMORAL STEM 16X100MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016
POLISHED IBEAM TIB TRAY 71MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·July 11, 2016
NON-POROUS PERF TIB TRAY-XSML
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·March 23, 2018
POLISHED FINNED TIBIAL TRAY 71 MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·March 10, 2017
POLISHED FINNED 1 PIECE TIBIAL TRAY
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·October 12, 2017
POLISHED FINNED TIBIAL TRAY 75MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·July 10, 2017
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·February 8, 2013
OPTEASE VENA CAVA FILTER
FDA Adverse Event
Malfunction
·CORDIS EUROPA, N.V.·Product code DTK·January 6, 2011
COYOTE? ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·July 22, 2014
MAXIM PRIMARY FEMORAL COMPONENT 75 MM LEFT / POROUS 75 LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 30, 2017
DCM MAXIM PRIMARY TIBIAL BEARING 12 MM THICK X 71/75 WIDE ARCOM UHMWPE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 30, 2017
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024