BEUDAMED
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    QUANTA LITE SS-B ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    MOBICATH TRANSSEPTAL NEEDLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sentimag System

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

    ACCESS® TOXO IGG

    FDA Adverse Event
    BECKMAN COULTER, INC.·Product code LGD·February 17, 2012

    SENSAR

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·January 18, 2013

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NVZ·December 13, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 5, 2014

    NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code LZO·March 7, 2014

    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

    FDA Recall
    Terminated ·Exactech, Inc.·Product code OLO·July 11, 2017

    Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code JDI·November 7, 2016

    Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6

    FDA Recall
    Terminated ·Exactech, Inc.·Product code LZO·November 7, 2016

    Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code KWS·August 31, 2017

    Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code KWS·August 31, 2017

    AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code LPH·November 7, 2016

    Exactech Optetrak Logic CC 15mm Tibial Augment Screws

    FDA Recall
    Terminated ·Exactech, Inc.·Product code JWH·April 7, 2017

    Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code GFC·May 30, 2013

    Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip

    FDA Recall
    Terminated ·Exactech, Inc.·Product code LXH·May 22, 2017

    Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code LZO·November 5, 2012

    Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code LZO·November 5, 2012

    Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty

    FDA Recall
    Terminated ·Exactech, Inc.·Product code KWS·June 15, 2012