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

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VENTRICULAR ACCESS SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

UCC DENTAL MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

Huvex Interspinous Fusion System

FDA 510(k)
FDA Class 2 ·Orthopedic

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 31, 2023

SERVO-I

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·February 20, 2014

OXYGEN MASK

FDA Adverse Event
Other ·MIZUHO ORTHOPEDIC SYSTEMS, INC.·Product code BYG·November 15, 2010

RESTYLANE INJECTABLE GEL

FDA Adverse Event
Other ·Q-MED AB·Product code LMH·August 30, 2010

BD FACSCALIBUR FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 24, 2023

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024