BEUDAMED
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    S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor provides a means to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network.

    FDA Enforcement
    Class II ·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020

    S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor provides a means to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network.

    FDA Recall
    Terminated ·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020

    Vl DBL OFFST WI LRG STPL, RT Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

    VI DBL OFFST W/ LRG STPL, LT Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

    VI DBL OFFST W/ LRG STPL, LT Nonsterile

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 20, 2014

    Vl DBL OFFST WI LRG STPL, RT Nonsterile

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 20, 2014

    CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

    FDA Enforcement
    Class II ·Terminated·AZIYO BIOLOGICS·October 16, 2019

    Depuy brand LCS Complete metal backed patella, cemented, LRG; REF 1294-09-760.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·June 7, 2005

    Depuy brand LCS Complete metal backed patella, porocoat, LRG+; REF 1294-09-670.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·June 7, 2005

    Depuy brand LCS Complete metal backed patella, porocoat, LRG; REF 1294-09-660.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·June 7, 2005

    Depuy brand LCS Complete metal backed patella, cemented, LRG+; REF 1294-09-770.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·June 7, 2005

    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 Enforcement
    Class II ·Terminated·Ossur Americas·March 20, 2019

    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 Enforcement
    Class II ·Terminated·Ossur Americas·March 20, 2019

    INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·February 26, 2014

    INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HSB·October 11, 2013

    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

    MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LRG·June 2, 2014

    MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LRG·December 2, 2020

    MicroScan WalkAway-96 plus Reconditioned Instrument

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LRG·September 4, 2019

    MicroScan WalkAway-40 plus Instrument

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LRG·September 4, 2019