BEUDAMED
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    AQUARIUSNET SERVER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040008522·Zirlux 16+ 0M2 89x17x18

    24PW - PG&E - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588120867·24PW - PG&E - Poly White

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521012086D0·12 x 85 mm SI Implant with HA Coating

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01208N0·Cervical Trial, 15 x 12, 8mm, 0 Degree, No Taper

    INSET 30

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 4, 2025

    REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    PRIMAFLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 13, 2022

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 15, 2012

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 9, 2015

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 27, 2013

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 15, 2022

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 14, 2007

    ULTAMET MTL INS NEUT 36MM 52OD

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·March 20, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 4, 2011

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 29, 2016

    INSET 30

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 4, 2025

    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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024