10 results
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19ms
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Sources: EU EUDAMED, US FDA
PROGRESSIVE RESISTANCE EXERCISE CUFF
FDA 510(k)
FDA Class 1
·Physical Medicine
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435061264·MCD Screw.2.3 x 18 mm M1
non lo...
Legacy
FDA UDI
Gc Orthodontics America Inc.·E53582361800001·LEGACY 1. MOLAR LWR LFT SZ 18
AXERA 2 ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SONICAID ONE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PRIME CARE 900
FDA Adverse Event
Malfunction
·PRIMUS MEDICAL LLC·Product code FNL·February 28, 2014
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·November 2, 2012
PROXIMATE ILS STRAIGHT STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·August 16, 2007
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Number314-06-33, c) 44, 47, 50, 53 head, Large, Item Number 314-06-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-35; 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