BEUDAMED
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    REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828101851·GEN4 Direct Access

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551046349·TWIST DRILL BIT

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828107112·GEN4 Direct Access

    PMT Drill Cutter

    FDA UDI
    adeor Medical AG·04251388941102·

    MODIFICATION TO ALPHA DX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK COMPACT PLUS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·January 11, 2007

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 14, 2023

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·August 25, 1999

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025

    IMPL-INSERTER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code FZX·May 9, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·September 19, 2014

    M2A MAGNUM PF CUP 50MM OD X 44MM ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 25, 2011

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026

    TRANSPAC IT MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, 30ML FLUSH (FOR USE WITH

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·April 15, 2021

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 11, 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 2120 (21-2120, 21-2125, and 21-2127) 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