14 results
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26ms
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Sources: EU EUDAMED, US FDA
PAPILLOTOMES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PressON™
FDA UDI
NEXUS SPINE, L.L.C.·B6788202400·Straight Steffee Probe – Ball Handle (1.8”)
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376248639·CoCr Straight Rod, 4.0mm X 240mm
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955932014·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955929816·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955930911·Percutaneous Transluminal Angioplasty Balloon C...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197494540·Micro Forceps
0,5mm ...
SLIM GLIDING NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Vinyl Co-Polymer Powder-free Examination Gloves, Black
FDA 510(k)
FDA Class 1
·General Hospital
REMB UNIVERSAL DRIVER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·May 20, 2014
PROMUS ELEMENT ¿ LONG
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 6, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2015
3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018
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