11 results
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21ms
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Sources: EU EUDAMED, US FDA
QWIKSPIN (TM)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490482356·PLATE 6860172 72.5MM ANTERIOR CERVICAL
P.F.C.
FDA UDI
DEPUY (IRELAND)·10603295215509·P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED ...
ORTHOMED
FDA UDI
ORTHO-MED, INC.·B8038601720·NERVE RETRACTOR LONG
REMA SHAVER BLADES
FDA 510(k)
FDA Class 2
·Orthopedic
Laparoscope Lens Shield Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ATTAIN OTW
FDA Adverse Event
Malfunction
·MPRI·Product code LWP·June 10, 2014
NELLCOR N20E
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEATLHCARE·Product code DQA·November 21, 2012
ALLEGRETTO WAVE EYE-Q EXCIMER LASER
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·June 22, 2015
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012