12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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