BEUDAMED
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    CLEAR-VIEW MIRROR WARMER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013387·Post Op Telescoping Knee Brace

    SELLAS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331

    FDA 510(k)
    FDA Class 2 ·Neurology

    UNKNOWN - UNSPECIFIED BY THE COMPLAINT

    FDA Adverse Event
    Injury ·COOK BIOTECH INCORPORATED·Product code FTM·April 3, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·October 18, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007

    MEDISLIM

    FDA Adverse Event
    Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

    DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HBX·December 3, 2010

    DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Distribution Only) Product Code: 281102 Fluid Tissue Management

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HBX·December 3, 2010

    DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing Product Code: 281103 Fluid Tissue Management

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HBX·December 3, 2010

    PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.

    FDA Recall
    Terminated ·Apheresis Technologies, Inc.·Product code FIR·November 29, 2010

    Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic).

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code LXH·June 27, 2011

    Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm) Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine BR Anchor System is indicated for use in soft tissue bone fixation.

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code JDR·April 29, 2008

    DePuy Mitek GRYPHON T BR Anchor w/ORTHOCORD Product Code: 210812 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MBI·February 24, 2011

    DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD Product Code: 210813 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MBI·February 24, 2011

    DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MBI·February 24, 2011

    DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD Product Code: 210814 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MBI·February 24, 2011

    Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code GEI·June 7, 2010

    Mitek VAPR Side Effect Short Electrode (integrated) Product Code: 227211 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code GEI·June 7, 2010