19 results
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23ms
·
Sources: EU EUDAMED, US FDA
Ricoh 3D for Healthcare Bolus
FDA 510(k)
FDA Class 2
·Radiology
Armada
FDA UDI
Nuvasive, Inc.·00887517220325·ARM15T CoCr Rod, 25mm Conventional PB
Minit®
FDA UDI
ZIMMER SPINE, INC.·00889024334106·
MORRISON MEDICAL
FDA UDI
MORRISON MEDICAL, LTD·00647921253025·CORR.PLSTC.SPLNT.18"CTR.FM./25
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221049827·Unitek(TM) Permachrome Resilient Stainless Stee...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011253025200·ceraMotion® Lf Base Dentin 5, 20 g / dental cer...
Turbett Surgical Container
FDA 510(k)
FDA Class 2
·General Hospital
JOSTRA HLM TUBING SET
FDA 510(k)
FDA Class 2
·Cardiovascular
M/DN®
FDA UDI
Zimmer, Inc.·00889024042803·
ITST®
FDA UDI
Zimmer, Inc.·00889024042797·
M/DN®
FDA UDI
Zimmer, Inc.·00889024042780·
M/DN®
FDA UDI
Zimmer, Inc.·00889024042773·
ECHELON 60 ENDOPATH STAPLER LONG ENDOSCOPIC LINEAR CUTTER - STRAIGHT 60 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GDW·December 9, 2008
ABL825 FLEX
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code CHL·August 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 29, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 26, 2011
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·November 28, 2011
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·June 10, 2015
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