19 results · 25ms · Sources: EU EUDAMED, 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