19 results · 23ms · Sources: EU EUDAMED, US FDA

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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