12 results
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25ms
·
Sources: EU EUDAMED, US FDA
MENTOR RAPID-SPAN (TM) TISSUE EXPANDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Gill
FDA UDI
The Radebaugh-Fetzer Company·00850047707291·G-99 Nail Rasp Double-Ended
UniTip Catheter
FDA UDI
Unisensor AG·07640172972410·
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011883303180·dentaform® Band, tooth 26, size 3/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011883303220·dentaform® Band, tooth 26, size 3/Roth 22
Brainsway Deep TMS System
FDA 510(k)
FDA Class 2
·Neurology
LANDLEX, MODEL: 402X
FDA 510(k)
FDA Class 2
·Physical Medicine
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 20, 2014
PHILOS II DR-T
FDA Adverse Event
Other
·BIOTRONIK SE & CO. KG·Product code NVZ·October 22, 2010
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 21, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020