BEUDAMED
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    VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls.

    FDA Enforcement
    Class II ·Terminated·The Binding Site Group, Ltd.·March 18, 2020

    VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls.

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code GRP·August 12, 2018

    McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HIB·April 13, 2015

    Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code HIB·October 2, 2015

    BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

    FDA Enforcement
    Class II ·Terminated·Numed Inc·May 21, 2025

    BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

    FDA Recall
    Terminated ·Numed Inc·Product code NVM·April 21, 2025

    VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.

    FDA Recall
    Terminated ·DJO, LLC·Product code JOW·May 28, 2013

    GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285. Indicated for the quantitative determination of plasma renin activity (PRA) by the radioimmunoassay of generated angiotension I.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code CIB·October 12, 2009

    Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HAB·May 6, 2011

    Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    Biomet Stablecut Saw Blade - Reprocessed Sterile device -- Powered Saw and Accessories.

    FDA Recall
    Terminated ·Ascent Healthcare Solutions, Inc.·Product code HAB·March 11, 2008

    Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CIB·January 20, 2012

    Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HAB·May 6, 2011

    Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro diagnostic use

    FDA Recall
    Terminated ·Perkinelmer Life Sciences, Inc.·Product code CIB·July 28, 2003

    Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories.

    FDA Recall
    Terminated ·Ascent Healthcare Solutions, Inc.·Product code HAB·March 11, 2008

    Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017