8 results
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18ms
·
Sources: EU EUDAMED, US FDA
RMC TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014
LIGACLIP ENDOSCOPIC ROTATING MULTPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGAT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·December 12, 2007
IMPLANT PDS30006PK PILLAR PALATAL EN
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code LRK·October 29, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012