11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CL24N
FDA 510(k)
FDA Class 2
·Radiology
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657006170·AED Endoscope - Sinuscope 2.70mm x 0 degree, 175mm
Plateau-V Spacer System
FDA UDI
Life Spine, Inc.·00190837028923·PLATEAU-V Interbody, Straight, Bulleted, 12mm x...
Paneffort AAMI Level 3 Isolation Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER
FDA Adverse Event
Injury
·BD·Product code JKA·February 11, 2013
POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-14MM-STERILE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·November 4, 2014
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·August 25, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 12, 2013
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 14, 2025
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018