BEUDAMED
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    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113264·SIDEPORT KNIFE 1MM ANGLED (BX/5)

    Affirm Contrast Biopsy

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)

    BIOCHECK TESTOSTERONE EIA, MODEL BC-1115

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    APNEACHECK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LUCIRA CHECK-IT COVID-19 TEST

    FDA Adverse Event
    Malfunction ·PFIZER, INC.·Product code QJR·August 1, 2023

    CHECK-IT

    FDA Adverse Event
    Malfunction ·PFIZER, INC.·Product code QJR·May 8, 2023

    WATCHMAN FLX?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·March 6, 2026

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code MDS·August 2, 2011

    MESH-COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 17, 2014

    TYVASO INHALATION SYSTEM

    FDA Adverse Event
    Malfunction ·UT GMBH·Product code CAF·July 1, 2013

    GST GOLD RELOAD 60MM 6 ROW

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 18, 2025

    WALLFLEX BILIARY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code PNB·May 25, 2026

    UNKNOWN_NEUWAVE

    FDA Adverse Event
    Injury ·NEUWAVE MEDICAL, INC.·Product code NEY·November 13, 2024

    UNKNOWN PROGRIP MESH PRODUCT

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION SAS·Product code FTL·February 6, 2023

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025