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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SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517570949·CoRoent Ant TLIF Ti, 14x11x34mm 8°
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695502P241348S1·PLIF 24mm x 8mm x 13mm x 4 °, TyPEEK, Sterile
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695302P241348S1·PLIF 24mm x 8mm x 13mm x 4 °, PEEK, Sterile
Portex
FDA UDI
ICU MEDICAL, INC.·15019517085235·
VISCO SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
FDA 510(k)
FDA Class 2
·Anesthesiology
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 10, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·September 2, 2011
11.25CM ATTACHMENT, BM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GFF·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