11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ARTHROSCOPIC SHOULDER HOLDER
FDA 510(k)
FDA Class 1
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526781696·LUMBAMED FACET 3 POINT SILVER II
GC Initial™
FDA UDI
Gc America Inc.·15400556703608·GC Initial™ MC/Paste Opaque Classic Line PO-CL ...
GC Initial™
FDA UDI
Gc America Inc.·J0228702121·GC Initial™ MC/Paste Opaque Classic Line PO-CL ...
Patterson
FDA UDI
PATTERSON DENTAL SUPPLY, INC.·D6620708702121·FILE, PULP CANAL, ENDODONTIC
CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM)
FDA 510(k)
FDA Class 2
·Cardiovascular
PROLITH MODEL 21S CARDIAC PULSE GEN.
FDA 510(k)
FDA Class 3
·Cardiovascular
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 12, 2014
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·December 12, 2012
ACRYSOF TORIC IOL
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. - HUNTINGTON·Product code MJP·June 25, 2015
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