9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XenMatrix AB Surgical Graft
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARROW REVERSE SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COGENT MED-LIF XL
FDA 510(k)
FDA Class 2
·Orthopedic
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
SIMPLEX P-JAPANESE TWIN PACK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·July 7, 2011
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013
TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·September 16, 2008
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