BEUDAMED
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    MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0316920·Probe, 1.75" Egg, Steffee, Long, Straight, Impact

    MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    GLYCOSAL HBA1C TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEPUY ASR XL FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 2, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 16, 2011

    MICROSTAAR INJECTOR CARTRIDGE

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code KYB·April 18, 2008

    Non-continuous ventilator accessories under the following brand names: a) RP-P ComfortGel Cush and Flap model number 1031391 and b) RP-S ComfortGel Cush and Flap model number 1031392. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    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