10 results
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19ms
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Sources: EU EUDAMED, US FDA
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Q-FIX
FDA UDI
Smith & Nephew, Inc.·00885556724729·REUSABLE BONE PUNCH 2.8MM Q-FIX IMPLANT
PARAPOST PARACORE AUTOMIX 5ML
FDA 510(k)
FDA Class 2
·Dental
Ponto Bone Anchored Hearing System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2025
PUMP MMT-512LNAS PRDGM INS SK EN US LN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·December 4, 2008
SCORPIO PS FEMUR WAFFLE POSTS W/LFIT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·September 13, 2011
GYNECARE X-TRACT MOTOR DRIVE UNIT
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code HET·July 29, 2013
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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