12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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