BEUDAMED
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    NIDEK MULTICOLOR LASER PHOTOCOAGULATOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SUN ITALIA

    FDA UDI
    BLV Licht- und Vakuumtechnik GmbH·B5331102280·

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642117974·Modular Spacer, 38 mm (W) x 28 mm (L) x 17 mm (...

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal

    2.8 x 300 mm Surgibit Drill

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215055196·The saleable unit (device count) is 1, there ar...

    GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES

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

    VERSAPULSE MODEL P20 LASER SYSTEM

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

    RADICAL 7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·December 18, 2014

    RADICAL 7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·December 18, 2014

    RADICAL-7 COLOR SCREEN HANDHELD

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·May 29, 2015

    RDS3 DOCKING STATION

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·September 17, 2014

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 15, 2011

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 5, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 20, 2011

    ACCU-CHEK INFORM METER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·August 14, 2008

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 4, 2022

    INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015