BEUDAMED
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    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·August 28, 2019

    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code GEY·September 25, 2018

    AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code GEY·October 6, 2016

    ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code GEY·November 28, 2012

    System Console, Single Port, with irrigation Product Usage: Electric system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code GEY·October 6, 2016

    Autolube-III Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code GEY·October 6, 2016

    ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code GEY·October 29, 2009

    Autolube-III with 20ft hose Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code GEY·October 6, 2016

    GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code GEY·March 28, 2017

    GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code GEY·March 28, 2017

    Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code GEY·October 6, 2016

    GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; GE626SU; HI-LINE XS DISP.DIAM.BURR X-CRS.III D4.5; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code GEY·March 28, 2017

    Autolube-III with Irrigation Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code GEY·October 6, 2016

    Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code GEY·June 11, 2012

    D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code GEY·January 24, 2013

    D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code GEY·January 24, 2013

    AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code GEY·October 6, 2016

    Foot control irrigation system Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code GEY·October 6, 2016

    NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.

    FDA Recall
    Terminated ·Nico Corp.·Product code GEY·July 29, 2015

    ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch. Used to operate various surgical handpieces.

    FDA Recall
    Terminated ·Linvatec Corp.·Product code GEY·August 30, 2005