BEUDAMED
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    HESSLER COLON THERAPY DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776288518·LaLonde Skin Hook Forceps,

    0800,APS0,08,AV,N,LT,ICW

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828153294·0800,APS0,08,AV,N,LT,ICW

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209102839·KIT, MCI WALK - QL - RED

    ACUMED

    FDA UDI
    Acumed LLC·10806378043017·MTP Reamer Concave 12mm With QR

    MODIFICATION TO: SAVI APPLICATOR KIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO NC-STAT

    FDA 510(k)
    FDA Class 2 ·Neurology

    8" (20 CM) EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, Y-CONNECTOR, ROTATING L

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code ONB·April 27, 2022

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FSA·May 8, 2014

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 22, 2012

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·August 16, 2010

    regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

    DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP.

    FDA Recall
    Terminated ·Diagnostic Chemicals, Ltd.·Product code JFY·February 12, 2009

    DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine.

    FDA Recall
    Terminated ·Diagnostic Chemicals, Ltd.·Product code JFY·February 12, 2009

    regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.

    FDA Recall
    Terminated ·Diagnostic Chemicals, Ltd.·Product code CHH·November 10, 2010

    Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

    FDA Recall
    Terminated ·Sekisui Diagnostics P.E.I. Inc.·Product code JIF·November 29, 2016

    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.

    FDA Recall
    Terminated ·Sekisui Diagnostics P.E.I. Inc.·Product code LDP·January 22, 2016

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012