8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
SC1000 SCAN CONVERTER
FDA 510(k)
FDA Class 1
·Radiology
OIC MODEL J4 TMJ CPM
FDA 510(k)
FDA Class 1
·Physical Medicine
VALTRAC(R) INTRODUCER FORCEP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·September 28, 2018
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 16, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 10, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024