165 results
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26ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code LOM·December 18, 2012
AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNS·September 24, 2015
Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
FDA Recall
Terminated
·Galt Medical Corporation·Product code DYB·May 2, 2018
Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick, Extends 8.9 mm,***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT C323023789***. Cutting and Shaping bone including bones of the spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBC·May 9, 2011
AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
Cook brand Reorder # PLVTW-14.0-38-30-BNS. Silhouette Transitionless Peel-Away Introducer
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·June 10, 2004
The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.
FDA Recall
Terminated
·PerkinElmer LAS, Inc·Product code JLW·October 24, 2011