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

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Mobility Scooter

FDA 510(k)
FDA Class 2 ·Physical Medicine

Oticon

FDA UDI
Sbo Hearing A/S·05714464057658·OTICON PLAY PX 2 MINIRITE T C093

EMS PIEZON 707 BIK AND PIEZON 707 BIK LED

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

IMP,TSV,4.1MM,SBM,11.5

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·November 10, 2021

CER BIOLOXD MOD HD 36MM -3 NK

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LZO·November 10, 2014

LEAD MODEL UNKNOWN

FDA Adverse Event
Malfunction ·CYBERONICS INC·Product code LYJ·August 17, 2011

AFFINITY THREE BIRTHING BED

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code HDD·July 17, 2013

SAMSUNG GALAXY WATCH 5 PRO (Z9NL)

FDA Adverse Event
Malfunction ·SAMSUNG ELECTRONICS AMERICA, INC.·Product code QDA·May 26, 2026

REDUCED SIZE ONCOLOGY SALVAGE SYSTEM RS FEMORAL BUSHINGS SET/2

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KRO·June 6, 2017

ONCOLOGY SALVAGE SYSTEM RS NON-MODULAR SHORT TIBIAL BASE 59MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KRO·June 6, 2017

ORTHOPEDIC SALVAGE SYSTEM POROUS COATED IM STEM 10.5 X 90MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·June 6, 2017

ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KRO·June 6, 2017

ONCOLOGY SALVAGE SYSTEM LOCKING PIN

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·June 6, 2017

ORTHOPEDIC SALVAGE SYSTEM RS RESURFACING FEMORAL LEFT 3CM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KRO·June 6, 2017

ONCOLOGY SALVAGE SYSTEM TIBIAL BUSHING

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·June 6, 2017

REDUCED SIZE ONCOLOGY SALVAGE SYSTEM RS AXLE

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KRO·June 6, 2017

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