18 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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