23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Cardiovascular
Surgimedics®
FDA UDI
COASTAL LIFE TECHNOLOGIES, INC.·00814716020098·Smoke Evacuation Filter
ERA Angled 2.2mm Implant Micro 15X4mm, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549107245·The ERA implant enables the transitional functi...
BIRMINGHAM HIPTM RESURFACING
FDA UDI
Smith & Nephew, Inc.·03596010503480·BHR CHECK JIG MAIN BODY
Vitacrilic®
FDA UDI
FRICKE INTERNATIONAL, INC.·B7159013000·Cross Link Monomer
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756018937·SLING & SWATHE
GC KommonBaseTM
FDA UDI
Gc Orthodontics America Inc.·E53590130000001·GC KommonBaseTM LV Pink 2 syringe pack
D. R. MEDICAL CONTROLLED PRESSURE GARMENTS
FDA 510(k)
FDA Class 2
·General Hospital
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
FDA 510(k)
FDA Class 2
·Dental
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 8, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 17, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 31, 2025
BMET ARCOM AP PAT W/WIRE 31MM IRE 31MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·May 5, 2022
Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
BIOMET ILOK PRI TIB TRAY 63MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 5, 2022
VNGD CR TIB BRG 10X63/67 MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 5, 2022
BIOMET FINNED PRI STEM 40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 5, 2022
AFFIXUS HFN 130 DEG 11MM X 180MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·August 13, 2018
AFFIXUS HFN 130 DEG 11MM X 180MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·August 13, 2018