13 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490482387·PLATE 6860180 80 MM ANT CERV
P.F.C.
FDA UDI
DEPUY (IRELAND)·10603295215578·P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED ...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955932885·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955931789·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955930683·Percutaneous Transluminal Angioplasty Balloon C...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197512633·Balfour-US Abdominal Retractor w ratchet
spread...
Intermittent Pneumatic Compression system
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOSET XC
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 10, 2014
NELLCOR N20PA
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·November 21, 2012
UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSA·September 21, 2010
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