11 results
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18ms
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Sources: EU EUDAMED, US FDA
SURGIKEK PENILE PROSTHESIS TAIL EXTEND
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ihcDirect® Napsin A Ab, 5mL
FDA UDI
NOVODIAX, INC.·00850000596702·Clone R1010
ihcDirect® Napsin A Ab, 15mL
FDA UDI
NOVODIAX, INC.·00850000596719·Clone R1010
ihcDirect® Napsin A Ab Conjugate 15mL
FDA UDI
NOVODIAX, INC.·00850030934741·Clone R1010
ihcDirect® Napsin A Ab Conjugate 5mL
FDA UDI
NOVODIAX, INC.·00850030934734·Clone R1010
ARTHREX SPEEDCINCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MBT CEM KEEL TIB TRAY SZ5
FDA Adverse Event
Injury
·DEPUY IRELAND REG. # 9616671·Product code NJL·May 27, 2014
MANDIB-PL-2 4HO L23 TI
FDA Adverse Event
Injury
·SYNTHES·Product code JEY·November 14, 2012
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 3, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024