16 results
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24ms
·
Sources: EU EUDAMED, US FDA
LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOQTEQ®
FDA UDI
aap Implantate AG·04042409398667·LOQTEQ® VA Metatarsal Straight Plate 2.5, 7 hol...
ArteVu
FDA 510(k)
FDA Class 2
·Cardiovascular
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
FDA 510(k)
FDA Class 2
·General Hospital
IMP,TSV,4.1,13,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 9, 2023
G7 VIVACIT E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 19, 2026
AVENIR COMPLETE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·May 19, 2026
BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·September 2, 2025
BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·September 2, 2025
BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·December 13, 2024
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
SM104 MSERIES W5TH
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·August 11, 2011
UNKNOWN LANCING DEVICE
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 30, 2013
BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·January 31, 2023
BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·July 28, 2022
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