18 results · 36ms · Sources: EU EUDAMED, US FDA

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VIZION

FDA 510(k)
FDA Class 2 ·Microbiology

Medetz Surgical Instruments

FDA UDI
Medetz Surgical Instruments LLC·G2231122760·Vannas capsulotomy scissors, 3 3/8", curved 6mm...

POWERPRESS UNIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

TEMP 3

FDA 510(k)
FDA Class 2 ·General Hospital

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024

UNK_THERMOCOOL SF NAV

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code LPB·April 22, 2024

MERGE CARDIO

FDA Adverse Event
Malfunction ·MERGE HEALTHCARE SOLUTIONS INC.·Product code LLZ·October 20, 2023

PROCEED VENTRAL PATCH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·May 14, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

TRAUMA SERIES

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·April 29, 2011

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021

PRIMEADVANCED

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 19, 2014

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020