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