10 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
FDA 510(k)
FDA Class 2
·General Hospital
SpheRx
FDA UDI
Nuvasive, Inc.·00887517813725·SpheRx II Grip Reducer
devemed
FDA UDI
devemed GmbH·04061644029563·Caliper "Iwanson" | 10 cm
0-10 mm
Reicodent
FDA UDI
devemed GmbH·04061644052448·Caliper "Iwanson" | 10 cm
0-10 mm
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011
TWIST DRILL FOR 1.5MMX 4MM SCW
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 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