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

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PreXolid CAD/CAM abutments

FDA 510(k)
FDA Class 2 ·Dental

ORTHOFIX

FDA UDI
ORTHOFIX SRL·18059015375510·REVISION LOCKING SCREW L72.5MM D4.0MM

ORTHOFIX

FDA UDI
ORTHOFIX SRL·18059015375015·REVISION LOCKING SCREW L72.5MM D4.0MM STERILE

BETA

FDA UDI
Gc Orthodontics America Inc.·E53573K24017251·BETA-TITA KEYHOLE 17X25 24MM(5 PACK)(SO)

Universal Abutment

FDA UDI
BICON, LLC·00813110026842·Universal Abutment UA4 TP 15° - 2.5mm Post

BD FACSCANTO SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

Citregen Tendon Interference Screw and Citrelock

FDA 510(k)
FDA Class 2 ·Orthopedic

JDEVOLUTION PLUS

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·December 11, 2025

JDEVOLUTION PLUS

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·December 11, 2025

JDEVOLUTION PLUS

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·April 3, 2026

ASR ACETABULAR IMPLANT 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·September 9, 2011

8010042-2008-00137

FDA Adverse Event
Malfunction ·Product code CBK·August 26, 2008

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·July 22, 2013

BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025

BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025

BD FACS 7-COLOR SETUP BEADS 25 TESTS

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

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