112 results
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22ms
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Sources: EU EUDAMED, US FDA
Seneographe DMR Mammography X-Ray System (all versions)
FDA Recall
Terminated
·General Electric Med Systems·Product code IZH·February 6, 2004
00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML Rx, Sterile; 00597201504 Femur CR POR FM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Femur CR PRC FEM COMP SIZE DML Rx, Sterile; 00597001404 Femur CR PRC FEM COMP SIZE DMR Rx, Sterile; 00597001503 Femur CR PRC FEM COMP SIZE EML Rx, Sterile; 00597001504 Femur CR PRC FEM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile; 00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx, Sterile; 00597001434 Femur CR PRC SURF HDN FEM CO-NID DMR Rx, Sterile; 00597001533 Femur CR PRC SURF HDN FEM CO-NID EML Rx, Sterile; 00597001534 Femur CR PRC SURF HDN FEM CO-NID EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533 Femur CR POR SURF HDN FEM CO-NID EML, Rx, Sterile; 00597201534 Femur CR POR SURF HDN FEM CO-NID EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR FEM SURF HDN HATCP CMR, Rx, Sterile; 65597201433 Femur CR POR FEM SURF HDN HATCP DML, Rx, Sterile; 65597201434 Femur CR POR FEM SURF HDN HATCP DMR, Rx, Sterile; 65597201533 Femur CR POR FEM SURF HDN HATCP EML, Rx, Sterile; 65597201534 Femur CR POR FEM SURF HDN HATCP EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 00597101102 Provisional CR PROV FRM COMP SIZE AMR, Rx, Sterile; 00597101201 Provisional CR PROV FRM COMP SIZE BML, Rx, Sterile; 00597101202 Provisional CR PROV FRM COMP SIZE BMR, Rx, Sterile; 00597101303 Provisional CR PROV FRM COMP SIZE CML, Rx, Sterile; 00597101304 Provisional CR PROV FRM COMP SIZE CMR, Rx, Sterile; 00597101403 Provisional CR PROV FRM COMP SIZE DML, Rx, Sterile; 00597101404 Provisional CR PROV FRM COMP SIZE DMR, Rx, Sterile; 00597101503 Provisional CR PROV FRM COMP SIZE EML, Rx, Sterile; 00597101504 Provisional CR PROV FRM COMP SIZE EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code NEP·March 31, 2021
GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code RCE·January 31, 2011
MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the lesion. Product Codes 47020, 475201, 477201,479201, and 470201 do not have the ultrasound enhancement shown in Figure 1. In addition,Product Codes 475201, 477201, 479201, and 470201 may be placed under MRI guidance. .
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code GDF·March 28, 2017
00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 Femur CR POROUS FEM COMP SIZE BML Rx, Sterile; 00597201202 Femur CR POROUS FEM COMP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE BML, Rx, Sterile; 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR, Rx, Sterile. Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area
FDA Recall
Terminated
·Asahi Medical Co., Ltd·Product code FJI·October 12, 2006
65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; 00597001231 Femur CR PRC SURF HDN FEM CO-NID BML, Rx, Sterile; 00597001232 Femur CR PRC SURF HDN FEM CO-NID BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx, Sterile; 00597201232 Femur CR POR SURF HDN FEM CO-NID BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 7, 2013
Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code DDR·September 27, 2007
RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA).
FDA Recall
Terminated
·Thera Test Laboratories, Inc.·Product code DHR·March 29, 2012
Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
FDA Recall
Terminated
·Zeus Scientific Inc·Product code DHR·November 9, 2001