2,370 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CADD PLUS
FDA Adverse Event
Injury
·SIMS DELTEC·Product code FRN·June 4, 1997
ARTHREX
FDA Adverse Event
Injury
·ARTHREX·Product code MAI·October 25, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 17, 2014
SABRATEK 6060 HOMERUN PUMP
FDA Adverse Event
Malfunction
·BAXTER/SABRATEK CORP.·Product code FRN·November 22, 2004
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·September 30, 2020
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 8, 2012
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 8, 2012
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 8, 2012
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 21, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 21, 2011
EXTENSION SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 21, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 21, 2011
BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION
FDA Adverse Event
Injury
·BD CARIBE, LTD·Product code GMQ·November 27, 2017
BD MACRO-VUE RPR CARD TEST
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GMQ·June 4, 2021
BD MACRO-VUE¿ RPR CARD TEST
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GMQ·June 8, 2022
BD MACRO-VUE¿ RPR CARD TEST
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GMQ·June 14, 2022
CAPTURE-S
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code GMQ·April 13, 2007
SCIMEDX FTA DS8400
FDA Adverse Event
Malfunction
·SCIMEDX·Product code GMQ·June 27, 2007
CAPTURE-S
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code GMQ·November 13, 2008
BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GMQ·August 26, 2021