18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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