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    PARA 4

    FDA 510(k)
    FDA Class 2 ·Hematology

    DD cubeY® HL

    FDA UDI
    Dental Direkt GmbH·EDDIG8420171·The DD cubeY® HL zirconium dioxide milling blan...

    Ophthalmic Scissors

    FDA UDI
    KATENA PRODUCTS, INC.·00841668105184·TERRY MICRO CORNEAL SCISSORS LEFT

    X-PORTE ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BAHA DIVINO

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NA

    FDA UDI
    Zimmer, Inc.·00889024193826·

    NA

    FDA UDI
    Zimmer, Inc.·00889024193833·

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 31, 2014

    PATHFINDER¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·November 21, 2012

    REPAIR CORE U DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·August 26, 2010

    SYSTEM 002-1100 15W THERMAL THERAPY

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code GEX·November 9, 2017

    SYSTEM 002-1100 15W THERMAL THERAPY

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code GEX·November 9, 2017

    ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·November 23, 2016

    ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·November 23, 2016

    ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·September 21, 2022