13 results
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28ms
·
Sources: EU EUDAMED, US FDA
3M PRECISE BRAND INTERNAL SURGICAL STAPLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bosworth Gorilla Seal
FDA UDI
Harry J Bosworth Company·H66809210511·LC Sealant Refill
PAQ.210X300X200/QT-75HS.KENZ1210
FDA UDI
AB MEDICA GROUP, S.A.·08428763009887·
RIWO-ART
FDA UDI
Richard Wolf GmbH·04055207022177·TROCAR SLEEVE SLANT. CAP 5.5MM WL 60MM stainle...
CONCIERGE GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ANNULOFLO SYSTEM, MITRAL MODEL AR700
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN DEPUY PINNACLE METAL LINER
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 17, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 9, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2014
12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·August 11, 2017
11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·March 28, 2017
RT-5100 Refractor, a component of the Epic-5100 System.
FDA Enforcement
Class III
·Terminated·Nidek Inc.·December 26, 2018
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