16 results
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28ms
·
Sources: EU EUDAMED, US FDA
Hive Standalone Cervical System and Hive C Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Poly Per-Q-Cath Catheter
FDA UDI
Bard Access Systems, Inc.·00801741035005·Poly Per-Q-Cath Catheter 4F Dual-Lumen Basic Ki...
AIDI MultiPlatform Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI22541051·AIDI Bioperfect® MultiPlatform® Implant 5.4mm x...
AIDI MultiMargin Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI12541051·AIDI Bioperfect® MultiMargin® Implant 5.4mm x 1...
AIDI MultiPlatform Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI2254105A1·AIDI Bioperfect® MultiPlatform® Implant 5.4mm x...
AIDI MultiMargin Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI1254105A1·AIDI Bioperfect® MultiMargin® Implant 5.4mm x 1...
AIDI MultiMargin Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI125410501·AIDI Bioperfect® MultiMargin® Implant 5.4mm x 1...
AIDI MultiPlatform Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI225410501·AIDI Bioperfect® MultiPlatform® Implant 5.4mm x...
ACCUC-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 11, 2007
Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
FDA 510(k)
FDA Class 2
·Cardiovascular
Catalyst F1x Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·April 16, 2019
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 19, 2011
CONTAK RENEWAL 3
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·July 30, 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