10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTSMedia Semen Wash Medium
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SKYHAWK
FDA UDI
Orthofix US LLC·18257200087297·T-HANDLE, TORQUE LIMITING DRIVER
STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PHOTOSILK PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM - LARGE TITANIUM LI
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC·Product code FZP·November 21, 2008
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·August 16, 2011
PROGUIDE CHRONIC DIALYSIS CATHETER
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code MSD·July 18, 2013
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 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