10 results · 21ms · Sources: EU EUDAMED, US FDA

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Medical Diode Laser (M2-GK)

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

Alkaline Washing Solution

FDA UDI
TOKYO BOEKI MEDISYS INC.·04580262046818·

PuriLens Plus Preservative Free Saline

FDA 510(k)
FDA Class 2 ·Ophthalmic

ALADYN RIGID SPINE PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Injury ·DEXCOM, INC.·Product code QBJ·December 22, 2022

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 25, 2008

HAUSTED VIC VIDEOFLUOROSCOPIC CHAIR

FDA Adverse Event
HAUSTED PATIENT HANDLING SYSTEMS, LLC·Product code FZK·September 2, 2011

1.85MM X 16MM FLUTED ROUTER

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

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