BEUDAMED
    69 results · 14ms · Sources: EU EUDAMED, US FDA

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    ReSolve Halo - Open Back Halo Ring, Model Number: 505300D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.

    FDA Recall
    Terminated ·Ossur Engineering, Inc·Product code HAX·November 9, 2008

    ReSolve Halo - Open Back Halo Ring, Model Number: 510400D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.

    FDA Recall
    Terminated ·Ossur Engineering, Inc·Product code HAX·November 9, 2008

    Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HAX·September 8, 2014

    Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HAX·September 8, 2014

    Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY

    FDA Recall
    Terminated ·Ossur Americas·Product code HAX·June 21, 2018

    Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HAX·September 8, 2014

    Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/ CB Resolve Sterile Unit LRG; 515300C/ CB RESOLVE RING KIT SM-No App; 515400C/ CB RESOLVE RING KIT STD-No App; 515500C/ CB RESOLVE RING KIT LG-No App; 540C/ CB RESOLVE COMPONENT TRAY; 553CB/ CB RING TRAY SM; 554CB/ CB RING TRAY STD; 555CB/ CB RING TRAY LG; 505301C/ Kit Closed Back Halo Sm; 505401C/ Kit Closed Back Halo Md; 505501C/ Kit Closed Back Halo Lg

    FDA Recall
    Terminated ·Ossur Americas·Product code HAX·June 21, 2018

    Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB RESOLVE RING KIT LRG; 515300D/ OB RESOLVE RING KIT SM-No App; 515400D/ OB RESOLVE RING KIT STD-No App; 515500D/ OB RESOLVE RING KIT LG-No App; 540D/ OB RESOLVE COMPONENT TRAY

    FDA Recall
    Terminated ·Ossur Americas·Product code HAX·June 21, 2018

    Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HAX·September 8, 2014

    Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HAX·September 8, 2014

    Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HAX·September 8, 2014

    Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT TI LG; 505500V2/ OB V2 RING KIT TI LG; 515300V2/ OB V2 RING KIT TI SM-No App; 515400V2/ OB V2 RING KIT TI STD-No App; 515500T/ CB RING KIT TI LG-No App; 515500V2/ OB V2 RING KIT TI LG-No App; 515300T/ CB RING KIT TI SM-No App; 515400T/ CB RING KIT TI STD-No App; 515301T/ CB RING KIT TI SM 8-No APP; 515301V2/ OB V2 RING KIT TI SM 8-No App; 515401T/ CB RING KIT TI STD 8-No APP; 515401V2/ OB V2 RING KIT TI STD 8-No APP; 515501T/ CB RING KIT TI LG 8-No App; 515501V2/ OB V2 RING KIT TI LG 8-No App; 540T/ STERILE TITANIUM COMP TRAY; 540V2/ STERILE V2 COMPONENT TRAY

    FDA Recall
    Terminated ·Ossur Americas·Product code HAX·June 21, 2018

    ReSolve Halo - Open Back Halo Ring, Model Number: 505400D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.

    FDA Recall
    Terminated ·Ossur Engineering, Inc·Product code HAX·November 9, 2008

    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems (Schweiz) Ag·September 18, 2013

    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·October 10, 2018

    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems (Schweiz) Ag·September 18, 2013

    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator

    FDA Enforcement
    Class II ·Terminated·Cardio Medical Products·July 17, 2013

    Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures

    FDA Enforcement
    Class II ·Terminated·Maquet Inc.·August 22, 2012

    Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053

    FDA Recall
    Terminated ·Linvatec Corp DBA Linvatec/Hal·Product code HWE·January 24, 2003

    Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271 5450

    FDA Recall
    Terminated ·Steris Corporation·Product code GDC·February 6, 2007