11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Blood Pressure Monitor (TMB-2092-G)
FDA 510(k)
FDA Class 2
·Cardiovascular
LCP
FDA UDI
Synthes GmbH·10886982166852·LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES...
Portex
FDA UDI
ICU MEDICAL, INC.·15019517085297·
Broach 35.5 size 1
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055363·
Maxima Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SILTEX CHP LUMERA GEL, 485CC
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·February 13, 2019
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 10, 2014
INSTATRAK 3500
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·August 17, 2011
IN TOUCH EU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·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