HYS - BEUDAMED

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

Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

FDA Recall

Open, Classified ·Brasseler USA I Lp·Product code EJL·January 11, 2024

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

Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7) MINOR PACK, REF DYNJ42132A; 8) RECTAL PRONE PACK, REF DYNJ43380A; 9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716; 10) CYSTO PACK, REF DYNJ47821F; 11) CYSTO PACK, REF DYNJ48978C; 12) CYSTO PACK, REF DYNJ50428C; 13) MID HUDSON CYSTO PACK, REF DYNJ53418B; 14) CYSTO PACK-LF, REF DYNJ55479D; 15) CYSTO PACK, REF DYNJ58445A; 16) MINOR PACK, REF DYNJ58566B; 17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431; 18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A; 19) FLEXIBLE CYS PACK, REF DYNJ62111C; 20) CYSTO PACK, REF DYNJ65830A; 21) MAIN & ODS CYSTO PACK, REF DYNJ66821A; 22) PROCEDURE CYSTO PACK, REF DYNJ68883; 23) CYSTO PACK, REF DYNJ69729; 24) MINOR SURGERY PACK, REF DYNJ80004; 25) LAPAROSCOPY PACK, REF DYNJ80763; 26) LAPAROSCOPY PACK, REF DYNJ80763; 27) CYSTO PACK, REF DYNJ82626; 28) MINOR PACK, REF DYNJ83155; 29) SY CYSTO, REF DYNJ900583M; 30) CYSTO, REF DYNJ905569B; 31) CYSTO, REF DYNJ907541A; 32) SET UP PACK-LF, REF LLSCASET01; 33) MAJOR PACK, REF SYNJ910011B

FDA Recall

Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FDE·September 4, 2024

NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E

FDA Recall

Open, Classified ·Product code BYS·October 11, 2023

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

NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E

FDA Recall

Open, Classified ·Product code BYS·October 11, 2023

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