14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPIRAL-FLEX
FDA 510(k)
FDA Class 2
·Anesthesiology
Full Blue X-ray Film WB
FDA UDI
CARESTREAM HEALTH, INC.·40889971860107·25SH 14X36IN BLUE X-RAY WB
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190790·FEMORAL LUG TRIAL 3mm HEX DRIVER
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981127138·14x13x5mm, 7 Degree Trial
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860105000·Standard Band, Tooth 15-14/24-25, Size 5
ORTHOMED
FDA UDI
ORTHO-MED, INC.·B8038601050·CAPSULE RETRACTOR TWO PRONG 10"
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860105180·Standard Band, Tooth 15-14/24-25, Size 5/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860105220·Standard Band, Tooth 15-14/24-25, Size 5/Roth 22
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
FDA 510(k)
FDA Class 2
·Cardiovascular
VPAP III ST-A/KIDSTA MASK SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014
VASOVIEW 7 XS
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·November 21, 2012
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 20, 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