11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
FDA 510(k)
FDA Class 2
·Cardiovascular
K2-HF OPAQUER powder, O-B1, 20g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38620060·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190608·Sizing Guide Bushing Neut/ +1mm
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177317·Modular Trial, 20 x 15 x 6mm, 7 Deg Lordosis
TRIANGULAR BANDAGE CAT.#191
FDA 510(k)
FDA Class 1
·Physical Medicine
LEGIONELLA DIRECT FLUORESCENT ANTIBODY
FDA 510(k)
FDA Class 2
·Microbiology
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·October 8, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·October 31, 2012
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·September 21, 2006
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