BEUDAMED
    74 results · 13ms · Sources: EU EUDAMED, US FDA

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    Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.

    FDA Recall
    Terminated ·Helena Laboratories, Inc.·Product code JJX·November 7, 2016

    16.5CM MICRO REVISION ATTACH, BLACK MAX

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    22CM MICRO REVISION ATTACH, BLACK MAX

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    9.4CM MICRO REVISION ATTACH, BLACK MAX

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·June 8, 2016

    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·June 8, 2016

    Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

    FDA Recall
    Terminated ·Helena Laboratories, Inc.·Product code JJY·October 14, 2016

    VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany Intended to be an intraoperative image guided localization system to enable minimally invasive surgery. Indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified to relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy.

    FDA Recall
    Terminated ·Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany·Product code MUJ·November 12, 2007

    Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code MRA·September 14, 2012

    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code MRA·April 12, 2016

    R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code MRA·March 11, 2011

    Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code MRA·April 12, 2016

    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code MRA·April 12, 2016

    Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code MRA·April 12, 2016

    Keramos Replacement Polyethylene Liner, 48mm; Cat. #496-28-048; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.

    FDA Recall
    Terminated ·Product code MRA·April 11, 2008

    Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries.

    FDA Recall
    Terminated ·Product code MRA·June 8, 2005

    Keramos Replacement Polyethylene Liner, 64mm; Cat. #496-28-064; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.

    FDA Recall
    Terminated ·Product code MRA·April 11, 2008

    Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MRA·June 9, 2009

    R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06 Usage: Primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis or traumatic arthritis

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code MRA·March 11, 2011

    R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code MRA·March 11, 2011