BEUDAMED
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    UNIPOLAR LEAD CONFIGURATION CONDUCTOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MGB Alert HSV Ensemble Primer Mix ASR - 480 rxn

    FDA UDI
    Elitechgroup Mdx LLC·03661540951350·MGB Alert® HSV Primer Mix contains chemically s...

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013400·Adjustable Elbow Brace, Right

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013394·Adjustable Elbow Brace, Left

    0800,APS0,08,N,L1,L2,TB,NV

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828152976·0800,APS0,08,N,L1,L2,TB,NV

    OXISCAN II DATA MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLORADO MICRODISSECTION NEEDLE

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

    BIODESIGN 4-LAYER TISSUE GRAFT

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

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W. L. GORE & ASSOCIATES·Product code MIH·October 16, 2012

    HARMONIC ACE 23CM W ERG HANDLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 16, 2010

    Compress Short Instruments Anchor Plug Holder, 12mm, stainless steel, non-sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF CP460193. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·July 18, 2008

    Compress/Finn Instrument Set Compress Anchor Plug Assembly, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF RD425032. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·July 18, 2008

    Compress Instrument Anchor Plug Holder, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481006. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·July 18, 2008

    Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedics, Inc., Warsaw, IN; REF CP461038. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·July 18, 2008

    Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481091. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·July 18, 2008

    Custom biomodular humeral tray 44 mm sterile, REF CP561686, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWS·April 22, 2011

    Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWS·April 22, 2011

    Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWS·April 22, 2011

    Custom comprehensive reverse shoulder bio-modular base 44 mm humeral tray standard, REF CP561510, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWS·April 22, 2011

    Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWS·April 22, 2011