17 results · 21ms · Sources: EU EUDAMED, 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