17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURABOND NON-PRECIOUS CERAMIC ALLOY
FDA 510(k)
FDA Class 2
·Dental
Atos Medical
FDA UDI
ATOS MEDICAL INC.·00817126020948·2010-069 Laryngectomy Pulmonary Kit with Standa...
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100190·SNII Tap, 7.50mm
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0100090·Tamp, Oblique Kicker
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100090·Dilator Sleeve, Screwdriver
KOKO PEAK KP; KOKO PEAK KP+
FDA 510(k)
FDA Class 2
·Anesthesiology
MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
FDA 510(k)
FDA Class 2
·Neurology
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 26, 2025
INSET I
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 19, 2025
1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER
FDA Adverse Event
Injury
·SYNTHES USA·Product code JEY·November 2, 2012
AXSYM DIGOXIN III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 11, 2011
Newport Coast Basic Pack, part number 007484-1
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
SYRINGE 50ML LL
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 19, 2021
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012