11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Trexon Monofilament Synthetic Absorbable Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARROW-LOK
FDA UDI
ARROWHEAD DE LLC·00855967006073·ARROW-LOK 2.5-3.5mm / Length 30mm, Straight
ARROW-LOK
FDA UDI
ARROWHEAD DE LLC·00855967006172·ARROW-LOK 2.5-3.5mm / Length 30mm, Angled
Truliant
FDA UDI
Exactech, Inc.·10885862556738·TRIAL, TIBIAL INSERT, PS, SIZE 3
Bridge Occlusion Balloon
FDA 510(k)
FDA Class 2
·Cardiovascular
SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·April 24, 2018
MARISA
FDA Adverse Event
Injury
·ARJO MED AB LTD·Product code FSA·September 13, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 15, 2014
OT ULTRASMART METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 30, 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