BEUDAMED
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    BIOSIGN STEAM-24 BIOLOGICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032723·Baltic Denture System BDLoad ↓ Mn6 PLSEum2DFm B...

    REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PLATELETWORKS

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·March 29, 2013

    COMPOSIX MESH E/X

    FDA Adverse Event
    Injury ·DAVOL INC, SUB. C.R. BARD, INC.·Product code FTL·March 17, 2011

    BABYSAFE

    FDA Adverse Event
    Malfunction ·VITAL SIGNS, INC.·Product code BTM·March 31, 2008

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025