12 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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Kingcera Dental Zirconia Blank
FDA 510(k)
FDA Class 2
·Dental
ACETABULAR REAMER D.50
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489416026·
Acetabular reamer ø50mm
FDA UDI
Incipio Devices SA·07630055301543·Acetabular reamer for hip arthroplasty
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160182·Integra® Miltex® DeBakey Multi-Purpose Clamp, 8...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776090630·Debakey Multi Purpose Clamp
JMS SYSLOC A.V.FISTULA NEEDLE SET
FDA UDI
JMS SINGAPORE PTE LTD·08888483005413·SYSLOC AVF 16GX11/4" BE 30CM W/CLAMP
DX-D IMAGING PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
PANORAMA 1.0T
FDA 510(k)
FDA Class 2
·Radiology
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·November 20, 2008
WIRE COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·September 2, 2011
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 22, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014