BEUDAMED
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    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113806·VISCO CANNULA 30GA ANGLE 8MM

    Inion CompressOn Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034006734·ISOLA SPINE SYSTEM CLOSED HOOK 6.35 x 6.5mm

    UNIBLOCKER

    FDA UDI
    FUJI SYSTEMS CORPORATION·04544050123921·UNIBLOCKER is intended for one-lung ventilation...

    UNIBLOCKER

    FDA UDI
    FUJI SYSTEMS CORPORATION·04544050063715·UNIBLOCKER is intended for one-lung ventilation...

    1628664-2017-00362

    FDA Adverse Event
    Malfunction ·September 28, 2017

    PURE PECTUS

    FDA UDI
    KLS-Martin L.P.·00888118142320·LID, CASE, INSTRUMENTS

    ATAC CALCIUM REAGENT AND ATAC CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOSPHERE MEDICAL INFUSION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY

    FDA Adverse Event
    Malfunction ·B BRAUN MEDICAL, INC.·Product code CAZ·April 17, 2012

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 27, 2014

    INSYNC MAXIMO

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    BARD SOFT MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·September 3, 2025

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011

    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

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    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