11 results
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22ms
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Sources: EU EUDAMED, US FDA
LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
FDA 510(k)
FDA Class 2
·Cardiovascular
LATEX EXAMINATION GLOVE POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
FUSION CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·March 29, 2023
TPRLC 133 MP TYPE1 BM HO 10.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2024
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 18, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·July 15, 2013
G7 OSSEOTI 4 HOLE SHELL 56MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 23, 2024
BIOLOX DELTA CERAMIC FEM HD 36/0MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·May 28, 2024
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