BEUDAMED
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    Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis Valve) for use during vascular interventional procedures. Part No. FCL-051-00, Catalog No. HLS2507MCN; and Part No. FCL-051-02, Catalog No. HLS2507MCN.

    FDA Recall
    Terminated ·Thomas Medical Products Inc·Product code DYB·December 16, 2010

    Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath Sealing Adapter, Part No. FCL-094-03, Catalog No. SSSA-EW-09; SafeSheath Sealing Adapter, Part No. FCL-141-01, Catalog No. 369826; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07; Transvalvular Insertion Tool (TVI), Part #MIS-122-00, Catalog No. TVI-09; and CPS SafeSheath Sealing Adapter, Part No. XD-2754-00, Catalog No. 410195.

    FDA Recall
    Terminated ·Thomas Medical Products Inc·Product code DYB·December 16, 2010

    Focal Sim radiation therapy treatment planning system

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·December 19, 2014

    STERIS 4085, 5085 & 5085SRT Surgical Tables

    FDA Recall
    Terminated ·Steris Corporation·Product code FQO·May 14, 2010

    Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Sterile EO Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550

    FDA Recall
    Terminated ·Boston Scientific·Product code DQY·September 11, 2007

    Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system

    FDA Recall
    Terminated ·Cook Inc.·Product code FCL·April 15, 2016

    Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps UPN/Catalog Number: MOO513330 The Radial Jaw 4 Large Capacity Inner Pouch, 240cm UPN M00513330 is a single unit which is packaged into a Box of 20 units (UPN M00513331), and a Box of 80 units (UPN M00513334). Single packaged units of M00513330 are not sold individually.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FCL·May 6, 2010

    Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm UPN/Catalog Number: M00513334

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FCL·May 6, 2010

    Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Inner Pouch 240cm, Box 20 UPN/Catalog Number: M00513331

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FCL·May 6, 2010

    NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-2, 5082-102-2CL , and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112 and 30502-212 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-2, and 635-5084-103-2 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-104-2, 5082-104-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-113 and 30502-213 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-104-2 and 636-5084-104-2 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-2, 5082-105-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114 and 30502-214 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-2 and 637-5084-105-2 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·January 1, 2014

    NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part #s 5082-101-2, 5082-101-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #s 30502-110 and 30502-210 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #s 5084-101-2 and 633-5084-101-2 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-102-2, 5082-102-2CL, 671-5082-102-2, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-111 and 30502-211 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-102-2 and 634-5084-102-2 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·September 10, 2014

    TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·July 15, 2020

    OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·July 15, 2020

    ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

    FDA Enforcement
    Class II ·Terminated·Stryker Corporation·March 14, 2018