1,091 results · 13ms · Sources: EU EUDAMED, US FDA

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Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.

FDA Recall
Terminated ·Product code MCW·December 6, 2021

Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

FDA Recall
Terminated ·Integra Burlington MA, Inc.·Product code GYC·March 18, 2013

HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

FDA Recall
Terminated ·Catheter Research, Inc·Product code HGS·April 7, 2015

Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.

FDA Recall
Terminated ·Medela Inc·Product code HFS·May 18, 2011

X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code rad·September 7, 2004

X-ray, Computed Tomography, Model TSX101A

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code JAK·January 14, 2003

Digital Radiography System Model DFP-8000D/FPD,

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code JAA·November 10, 2005

Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code LNH·January 27, 2004

Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code IYN·October 2, 2007

NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Toshiba America Medical Systems, Inc., Tustin, CA.

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code IYO·August 29, 2007

Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system.

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code JAK·October 1, 2007

Magnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code LNH·August 24, 2004

Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code IYN·February 2, 2007

Digital Radiography System Model DFP8000D

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code JAA·November 10, 2005

High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code JAA·September 21, 2005

Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code IYN·May 23, 2005

Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system.

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code JAK·October 1, 2007

Toshiba Digital Radiography System Model DFP8000D

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code JAA·November 15, 2005

NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0,Toshiba America Medical Systems, Inc., Tustin, CA.

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code IYN·August 29, 2007

Computed Tomography, Models TSX-101A and TSX-021A.

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code JAK·March 17, 2004