16 results
·
34ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Silver Fluoride Hypersensitivity Varnish
FDA 510(k)
FDA Class 2
·Dental
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000857011·STRUT 6241041 ANATOMIC 14X11X5MM
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994305244·STRUT 6241041 ANATOMIC 14X11X5MM
NuVasive
FDA UDI
Nuvasive, Inc.·00887517179920·Universal T-Handle, Fixed ¼ Square
LCP
FDA UDI
Synthes GmbH·10886982165589·3.5MM LCP T-PLATE 3H HEAD/ 4H SHAFT/63MM-OBLIQU...
APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
FDA 510(k)
FDA Class 2
·Cardiovascular
NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
VERTE-STACK ANATOMIC PEEK STRUT
FDA Adverse Event
Injury
·MEDTRONIC·Product code MQP·December 1, 2015
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 10, 2014
CRE(TM) BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KOG·September 9, 2011
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 2013
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011
1030489-2016-01433
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 16, 2016
VERTE-STACK SPINAL SYSTEM CENTER STRUT
FDA Adverse Event
Injury
·MEDTRONIC·Product code MQP·December 19, 2015
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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