10 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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Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
FDA 510(k)
FDA Unclassified
·Unknown
ACETABULAR REAMER D.58
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489416064·
Acetabular reamer ø58mm
FDA UDI
Incipio Devices SA·07630055301628·Acetabular reamer for hip arthroplasty
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160205·Integra® Miltex® DeBakey Multi-Purpose Clamp
EXTRACTOR RX RETRIEVAL BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SURGICAL GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROLENE HERNIA SYSTEM
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·November 20, 2008
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·September 2, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·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