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

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    MODIFICATION TO TEMNO BIOPSY NEEDLES

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

    APC™ Flash-Free Victory Series™ Low Profile

    FDA UDI
    3M UNITEK CORPORATION·00652221232182·Victory Series(TM) Low Profile Bracket APC(TM) ...

    APC™ II Victory Series™ Low Profile

    FDA UDI
    3M UNITEK CORPORATION·00652221063694·Victory Series(TM) Low Profile Bracket APC(TM) ...

    APC™ PLUS Victory Series™ Low Profile

    FDA UDI
    3M UNITEK CORPORATION·00652221094728·Victory Series(TM) Low Profile Bracket APC(TM) ...

    NEEDLE 18X1-1/2 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·July 22, 2024

    ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220

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

    TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BD ANGIOCATH

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·May 9, 2024

    EXPLOR IMPLANT LOCKING SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWI·March 27, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 11, 2011

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008

    THROMBECTOMY

    FDA Adverse Event
    Death ·MEDOS INTERNATIONAL SARL·Product code DXE·October 19, 2022

    STENT - VASCULAR RECONSTRUCTION

    FDA Adverse Event
    Death ·MEDOS INTERNATIONAL SARL·Product code NJE·October 19, 2022

    Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 10, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018