23 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
HairCheck-DT (Opiates)
FDA UDI
Quest Diagnostics·00868586000223·HairCheck-DT (Opiates) is an ELISA test kit use...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809869941·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
FDA 510(k)
FDA Class 2
·Radiology
DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HARMONIC ACE 36 CM
FDA Adverse Event
Injury
·ETHICON ENDO SURGERY, INC.·Product code LFL·December 12, 2005
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75 X 14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75X14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 9, 2013
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TREATMENT
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·April 6, 2011
CONTAK RENEWAL 4 RF
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67X14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
VANGUARD DA 360 TIBIAL BEARING ARCM 71/75X16
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 28, 2017
VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·February 6, 2017
VG DA360 TIB BRG ARCM 79/83X14 3 X 14MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·October 31, 2017
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 2, 2017
VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 13, 2016
VANGUARD DA 360 TIBIAL TRAY
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 27, 2017
VANGUARD SSKPSC TIBIAL BEARING S 12X63/67
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 21, 2017
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020