BEUDAMED
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    HYDRO2, HS-75

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Genesys Spine Surgical Illuminator

    FDA UDI
    Lumitex, Inc.·00812432021153·

    S-LIFT®

    FDA UDI
    SPINEFRONTIER, INC.·00190361038467·TRIAL RASP, LORDOTIC, 19MM WIDE, 14MM

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033335772·

    BEAUTIFIL

    FDA 510(k)
    FDA Class 2 ·Dental

    CLEARFIL REPAIR

    FDA 510(k)
    FDA Class 2 ·Dental

    HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·July 9, 2014

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·January 24, 2019

    HUDSON QUICK-COUPL REAMING SPEED F/TRS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·March 19, 2013

    OPMI PENTERO

    FDA Adverse Event
    Other ·CARL ZEISS SURGICAL GMBH·Product code EPT·February 24, 2011

    GRIPPER PLUS NEEDLE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code FMI·March 10, 2008

    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·October 1, 2014

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    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