9 results
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28ms
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Sources: EU EUDAMED, US FDA
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Iris Retract
FDA UDI
KATENA PRODUCTS, INC.·00841668114346·FLEXIBLE IRIS RETRACTORS 5 PKS of 5
DentMix VPS Impression Material
FDA 510(k)
FDA Class 2
·Dental
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS·Product code LWS·November 11, 2008
ADEL OBS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HDD·August 11, 2011
MAQUET MAGNUS TABLETOP
FDA Adverse Event
Malfunction
·MAQUET GMBH·Product code FWZ·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
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026