21 results · 24ms · Sources: EU EUDAMED, US FDA

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IMPEACE and IMPEACE-Uni Anterior Cervical Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

PPD BALLOON DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S

FDA 510(k)
FDA Class 2 ·Dental

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 9, 2024

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 17, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 13, 2024

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 12, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 27, 2025

PUREPOINT

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQF·October 31, 2008

RUSCH

FDA Adverse Event
Malfunction ·TELEFLEX·Product code KOD·August 11, 2011

EPIC II VR

FDA Adverse Event
Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·September 25, 2024

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·July 13, 2023

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·May 23, 2024

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·June 7, 2024

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·November 28, 2024

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·October 31, 2023

M.U.S.T. MINI POLYAXIAL SCREW

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·August 11, 2025

EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).

FDA Enforcement
Class II ·Terminated·Haag-Streit USA Inc·March 29, 2017

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021