12 results
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26ms
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Sources: EU EUDAMED, US FDA
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TLX
FDA UDI
Nuvasive, Inc.·00887517730466·TLX Implant, 8x13x31mm 15°
UniTip Catheter
FDA UDI
Unisensor AG·07640172972410·
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011883305180·dentaform® Band, tooth 26, size 5/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011883305220·dentaform® Band, tooth 26, size 5/Roth 22
Crossing Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
HIGH DEFINITION LCD MONITOR
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code NWB·February 20, 2014
DEXTRUS 4136
FDA Adverse Event
Other
·BIOTRONIK SE & CO. KG·Product code NVZ·October 22, 2010
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·December 21, 2012
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
FDA Enforcement
Class I
·Terminated·Synthes, Inc.·August 27, 2014
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