12 results · 27ms · Sources: EU EUDAMED, US FDA

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TRIA FAN SYSTEM

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

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450407172·

MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)

FDA 510(k)
FDA Class 2 ·General Hospital

VASCUTRAK PTA DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

PRECISION MONTAGE MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 11, 2020

LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018

GOLVO

FDA Adverse Event
Malfunction ·LIKO AB·Product code FSA·March 26, 2013

EXPEDIUM 5.50 POLYAXIAL SCREW 7.00X40MM, TI

FDA Adverse Event
Injury ·DEPUY SPINE, INC.·Product code NKB·June 13, 2011

INVACARE POWER WHEELCHAIR

FDA Adverse Event
Injury ·INVACARE CORP. MANUFACTURING FACILITY·Product code ITI·August 20, 2008

Single Shot Epidural Tray Catalog Number: 6183R1

FDA Enforcement
Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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