12 results · 22ms · Sources: EU EUDAMED, US FDA

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Surgical Face Mask

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

Metzenbaum Scissors Curved 14cm

FDA UDI
CONCISE ENTERPRISES·G2021401825140·Metzenbaum scissors are a type of surgical scis...

NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TENS/EMS COMBO, EMS, TENS

FDA 510(k)
FDA Class 2 ·Neurology

INSYTE AUTOGUARD

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·February 27, 2026

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 17, 2014

TIEMAN CATHETER 100% SILICONE 2WAY 5CC

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code KOD·July 8, 2011

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 11, 2013

COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSD·September 26, 2023

COMPR NANO HMRL PPS 34MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 10, 2024

COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSD·March 21, 2024

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014