BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.

    FDA Recall
    Open, Classified ·The Biomed Guys·Product code FRN·March 25, 2021

    OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

    FDA Recall
    Open, Classified ·OPTI Medical Systems, Inc·Product code QJR·June 25, 2021

    RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)

    FDA Recall
    Open, Classified ·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·March 25, 2021

    Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HRS·October 25, 2021

    Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.

    FDA Recall
    Open, Classified ·Accelerated Care Plus Corporation·Product code ITX·August 25, 2021

    Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.

    FDA Recall
    Open, Classified ·Northgate Technologies, Inc.·Product code FFK·October 25, 2021

    OxyMask O2 Adult REF OM-1125-14

    FDA Recall
    Open, Classified ·Southmedic, Inc.·Product code CCK·May 25, 2021

    VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PCH·June 17, 2022

    Verigene CDF Nucleic Acid Test, Part No. 30-002-22

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZN·June 17, 2022

    HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code QLU·August 25, 2021

    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro/8/9/10000) Part Number: 0020302600

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·August 25, 2021

    cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190

    FDA Recall
    Open, Classified ·Roche Molecular Systems, Inc.·Product code QJR·March 25, 2021

    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro) Part Number: 0020302601

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code N/A·August 25, 2021

    cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190

    FDA Recall
    Open, Classified ·Roche Molecular Systems, Inc.·Product code QJR·March 25, 2021

    The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, d) Catalog # DWH046 - Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr, e) Catalog # DWH048 - Diameter 48 mm Height 18 mm Eccentric LOW (1.5) Material PyC/CoCr, f) Catalog # DWH050 - Diameter 50 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, g) Catalog # DWH051 - Diameter 50 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, h) Catalog # DWH052 - Diameter 52 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, i) Catalog # - DWH053 - Diameter 52 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, j) Catalog # DWH054 - Diameter 54 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, k) Catalog # DWH139 - Diameter 39 mm Height 14 mm Eccentric HIGH (3.5) Material PyC/CoCr, l) Catalog # DWH141 - Diameter 41 mm Height 15 mm Eccentric HIGH (3.5) Material PyC/CoCr, m) Catalog # DWH143 - Diameter 43 mm Height 16 mm Eccentric HIGH (3.5) Material PyC/CoCr, n) Catalog # DWH146 - 46 mm Height 17 mm Eccentric HIGH (4) Material PyC/CoCr, o) Catalog # DWH148, - Diameter 48 mm Height 18 mm Eccentric HIGH (4) Material PyC/CoCr, p) Catalog # DWH150 - Diameter 50 mm Height 16 mm Eccentric HIGH (4) Material PyC/CoCr, q) Catalog # DWH151 - Diameter 50 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, r) Catalog # DWH152 - Diameter 52 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, s) Catalog # DWH153 - Diameter 52 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr, t) Catalog # DWH154 - Diameter 54 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr,

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot St Martin France·Product code QHE·June 25, 2021