19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMARTBUILDER SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ArgenPMMA Multi 98x12-D2
FDA UDI
ARGEN CORPORATION, THE·D818120951·Crown And Bridge, Temporary, Resin
5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 2, 2020
H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDTOX BUPRENORPHINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 5, 2025
HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 9, 2023
HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 19, 2025
HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 6, 2025
ENDURO MENISCAL COMPONENT F2 22MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014
ENDURO MENISCAL COMPONENT F2 10MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 20, 2013
PINNACLE GRIPTION
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS·Product code LPH·June 3, 2011
IN TOUCH
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC LP·Product code FNL·August 13, 2008
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·January 14, 2011
ENDURO MENISCAL COMPONENT F1 10MM
FDA Adverse Event
Injury
·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016
HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 6, 2022
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
FDA Enforcement
Class II
·Terminated·Philips North America Llc·November 17, 2021