BEUDAMED
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    PENUMBRA EMBOLIZATION COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Signature III

    FDA UDI
    Rmo, Inc.·00885797101938·SIG III MBT.022 HK EXT 1 CS

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517635679·CoRoent Ant TLIF PEEK, 10x13x30mm 15°

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821053050·FORCEPS

    Zethon

    FDA UDI
    ZETHON LIMITED·05060528013345·PC-120 - POWER CONSOLE - LESS IRRIGATION

    Tsolution One Surgical System

    FDA UDI
    THINK SURGICAL, INC.·M9461033050·POST, RECOVERY MARKER 125

    NIAGARA® Lateral Access System

    FDA UDI
    VB Spine LLC·10888857523722·Cranial Caudal Blade Size 50 mm

    PEDIATRIC INGESTASCAN

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ENOXAPARIN TEST CARD

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

    MAGELLAN

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code FMI·February 18, 2025

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code KDJ·May 9, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·September 19, 2014

    PCA PLS II

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD·Product code FRN·May 16, 2011

    BD PHASEAL¿ OPTIMA INJECTOR N35-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·October 15, 2021

    MERIDIAN (model nos. 476, 976, 1176 and 1276) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. MERIDIAN pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, sine offering adaptive-rate therapy. MERIDIAN pacemakers use an accelerometer that allows the pacing rate to adapt to the patient's changing metabolic demand as it responds to patient activity.

    FDA Recall
    Terminated ·Guidant Corporation·Product code LWP·July 18, 2005

    Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021