2,370 results · 36ms · Sources: EU EUDAMED, 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