11 results
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29ms
·
Sources: EU EUDAMED, US FDA
OVAL CUP BIOPSY FORCEP (MODEL 18/5)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GC Initial™
FDA UDI
Gc America Inc.·J0228740121·GC Initial™ Ti Powder Opaque OC3, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556704681·GC Initial™ IQ/ Layering-over-Zircon Body BL, 250g
OHMEDA ANESTHESIA RECORD KEEPER
FDA 510(k)
FDA Class 2
·Anesthesiology
SIM MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·June 16, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 19, 2010
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 14, 2012
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·October 31, 2024
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·October 31, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024