BEUDAMED
    31 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed

    FDA Enforcement
    Class II ·Terminated·OMNIlife science Inc.·August 1, 2018

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

    FDA Enforcement
    Class II ·Terminated·OMNIlife science Inc.·September 11, 2019

    SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928

    FDA Enforcement
    Class II ·Terminated·OMNIlife science Inc.·February 3, 2021

    SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728

    FDA Enforcement
    Class II ·Terminated·OMNIlife science Inc.·February 3, 2021

    SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128

    FDA Enforcement
    Class II ·Terminated·OMNIlife science Inc.·February 3, 2021

    Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EVOLUTPRO-23 BLUE 6L COMM OUS, VLV EVOLUTPRO-23 PRO COMM 29L CAN, VLV EVOLUTPRO-23 PRO COMM 29L OUS SA, VLV EVOLUTPRO-23 PRO COMM 29L AUS; b. EVOLUTPRO-23-US, Labeled as: VLV EVOLUTPRO-23-US BLUE COMM US, VLV EVOLUTPRO-23-US PRO BLNK US; c. EVOLUTPRO-26, Labeled as: VLV EVOLUTPRO-26 PRO COMM 29L OUS, VLV EVOLUTPRO-26 BLUE 6L COMM OUS, VLV EVOLUTPRO-26 PRO COMM 29L AUS, VLV EVOLUTPRO-26 BLUE COMM JPN, VLV EVOLUTPRO-26 BLUE 29L COMM OUS, VLV EVOLUTPRO-26 PRO COMM 29L CAN, VLV EVOLUTPRO-26 PRO COMM 29L OUS SA; d. EVOLUTPRO-26-US, Labeled as: VLV EVOLUTPRO-26-US BLUE COMM US, VLV EVOLUTPRO-26-US PRO BLNK US; e. EVOLUTPRO-29, Labeled as: VLV EVOLUTPRO-29 PRO COMM 29L OUS, VLV EVOLUTPRO-29 BLUE 29L COMM OUS, VLV EVOLUTPRO-29 BLUE 6L COMM OUS, VLV EVOLUTPRO-29 PRO COMM 29L AUS, VLV EVOLUTPRO-29 BLUE COMM JPN, VLV EVOLUTPRO-29 PRO COMM 29L CAN, VLV EVOLUTPRO-29 PRO COMM 29L OUS SA; f. EVOLUTPRO-29-US, Labeled as: VLV EVOLUTPRO-29-US BLUE COMM US, VLV EVOLUTPRO-29-US PRO BLNK US g. , Labeled as:

    FDA Enforcement
    Class II ·Terminated·Medtronic Heart Valves Division·December 16, 2020

    Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·August 31, 2016

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013