23 results · 21ms · Sources: EU EUDAMED, US FDA

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PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

ACE

FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950018321·FORCEP TISSUE RUSSIAN 6" 15CM

Tiger Supply Inc.

FDA UDI
TIGER SUPPLY, INC.·D82360011081·Bite Registration Material Fast Set 2x50ml Cart...

MPS

FDA UDI
QUEST MEDICAL INC·00634624501188·MPS® Antegrade/Retrograde Y-Set

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001108·artVeneer life upper anteriors, BOS, A35

TruFlex

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730013866·NiTi Thermal Euro Upper 17x25 10 archwires per ...

TruFlex™

FDA UDI
Ortho Organizers, Inc.·00190707126551·TRUFLEX NiTi Thermal Euro Upper 17x25 (10pk)

PRCT2

FDA UDI
FX SOLUTIONS·03701037307618·PRCT II TRIAL HUMERAL PLATE LEFT 8 HOLES

RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921

FDA 510(k)
FDA Class 2 ·General Hospital

BD PHASEAL CONNECTOR LUER LOCK C35J

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 9, 2020

INJECTOR LUER LOCK N35C MULTIPACK

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·March 11, 2021

GORE® TAG® THORACIC ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·May 3, 2016

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013

FOUNDATION SHOULDER

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code KWS·February 16, 2011

LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·February 14, 2008

iBOT PMD with software version 01.05.24. Personal Mobility Device.

FDA Enforcement
Class II ·Ongoing·Mobius Mobility LLC·June 18, 2025

LENSX LASER SYSTEM

FDA Adverse Event
Injury ·ALCON - LENSX LASERS, INC.·Product code OOE·December 8, 2011

TECNIS IOL

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·April 18, 2025

Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·November 4, 2015