152 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304001466·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868558672·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868247965·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694052214·1.2mm Driver Stem, Long, Hex Shank
ARTHROJET XT
FDA 510(k)
FDA Class 2
·Orthopedic
SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PFNA BLADE PERF L100 TAN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HSB·June 15, 2017
VANGUARD DCM PS TIBIBAL BEARING 14MM X 71/75MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 10, 2017
TDCH 5, 110, RA/RA CATHETER KIT
FDA Adverse Event
Other
·ICU MEDICAL, INC.·Product code DYG·May 11, 2010
THERMOCOOL® SF BI-DIRECTIONAL CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·October 3, 2014
MEDISYSTEMS
FDA Adverse Event
MEDISYSTEMS·Product code FJK·May 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
PERFORMANCE TOTAL KNEE PROSTHESIS
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HRY·October 25, 2019
VANGUARD CRUCIATE RETAINING ILOK FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 19, 2017
VANGUARD PS OPEN POR FMRL LT 65
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·July 15, 2024
TD HEPARIN COATED CATHETER
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code DYG·October 17, 2016
UNKNOWN TRIAL POST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 21, 2022
BZO Strip Dip Card (300ng/ml)*, Item No. 100170
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
VIDAS HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·November 26, 2020