BEUDAMED
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    Cala Trio

    FDA 510(k)
    FDA Class 2 ·Neurology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517568786·CoRoent Ant TLIF Ti, 10x13x28mm 8°

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114131·BIMANUAL IRRIGATION 21GA END OPEN PK/10

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114285·LACRIMAL CAN TAPPERED 19/23GA

    ORIGEN DUAL LUMEN CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBRA BIPOLAR CLAMP, MODEL 15902

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2024

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·December 15, 2020

    LOGICAL CATH LAB SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, ASD.·Product code DRS·October 14, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 2, 2013

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021