13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MR4500 WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
BullDog®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734022986·Disposable Endoscope Valves Set
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017671·Hook Punch 15 degree up milled 3.5mm 30 degree ...
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026
STERN MICRO ERA ATTACHMENT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DEPUY UNIVERSAL GRIPTION TF CONES
FDA 510(k)
FDA Class 2
·Orthopedic
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 18, 2023
BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·September 23, 2020
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
ABGII. MODULAR STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code JDI·June 2, 2011
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015