BEUDAMED
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    BK-5315-01 FOAM HAND EXERCISER, SMALL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58208017100·RETRACTOR, ALL TYPES

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006748·VITROS Chemistry Products VALP Reagent

    Oph.Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668118153·Lambert Chalazion Forceps, Small, 8mm

    ACUMED

    FDA UDI
    Acumed LLC·10806378051104·Long Stem Reamer 10mm

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209131280·

    SURE-SNAP

    FDA UDI
    Gc Orthodontics America Inc.·E53580171000001·SURE-SNAP 2. MOLAR UPR RGT SZ 10

    LUXATEMP ULTRA /STAR

    FDA 510(k)
    FDA Class 2 ·Dental

    APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·February 11, 2014

    10MM DISTAL FEMORAL AUGMENT, SIZE: F

    FDA Adverse Event
    Injury ·ZIMMER TMT·Product code JWH·October 12, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007

    VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·February 27, 2019

    VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LEG·April 18, 2005

    VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY USA -- Ortho- Clinical Diagnostics High Wycombe, UK --- An in vitro diagnostic. For in vitro diagnostic use only. Used to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LEG·May 10, 2011

    VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LEG·December 11, 2018

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022