11 results
·
17ms
·
Sources: EU EUDAMED, US FDA
VASCULAR BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517391353·CoRoent® XL, 10x18x40mm
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756378710·CT/ULTRASOUND BIOPSY TRAY
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112298·SURG-I-BAND BLACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112342·SURG-I-BAND ORANGE GLOW
LIAC
FDA 510(k)
FDA Class 2
·Radiology
SYNPLUG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MIRA CR4000 OPHTHALMIC CRYO UNIT
FDA Adverse Event
Malfunction
·MIRA, INC.·Product code GEH·November 23, 2010
INGENIO
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 11, 2013
VANGUARD SSKPSC TIBIAL BEARING S 16X63/67
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 2, 2014
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020