23 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
CAPTURED HIP SCREW LAG SCREW
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
HHM
FDA UDI
Oticon A/S·05707131280824·H160V2, BTE 13 WL 100 SIL HHM
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868344275·
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304207806·
POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
FDA 510(k)
FDA Class 1
·Microbiology
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·June 6, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 6, 2011
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·October 8, 2014
UNK - SCREWS: TRAUMA
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·December 4, 2019
UNK - CONSTRUCTS: PLATE/SCREWS
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·December 4, 2019
UNK - SCREWS: TRAUMA
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·December 4, 2019
UNK - PLATES
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·December 4, 2019
UNK - PLATES: LISS
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·December 4, 2019
UNK - PLATES
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·December 4, 2019
UNK - SCREWS: TRAUMA
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·December 4, 2019