BEUDAMED
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    TKD SCALERS

    FDA 510(k)
    FDA Class 2 ·Dental

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040015599·Hemostat Halsted Mosquito 5"

    PowerPICC Provena

    FDA UDI
    Bard Access Systems, Inc.·00801741154713·Catheter Placement Kit

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496000846·MAGIC 30, SIZE XL, NERO, GRADUATED COMPRESSION ...

    ELIMINATOR

    FDA UDI
    Conmed Corporation·20653405052545·CONMED Eliminator® 3-stage Pyloric/Colonic PET ...

    STAINLESS STEEL RETAINER/BRACE

    FDA Adverse Event
    Injury ·UNITEK CORP.·Product code DYJ·February 22, 1994

    STAINLESS STEEL RETAINER

    FDA Adverse Event
    Injury ·PETER CHENG LABORATORY·Product code DYJ·February 22, 1994

    KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RADIOCAMERAS EXTRACRANIAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELIMINATOR PET

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code KNQ·October 4, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

    PRISM HIV O PLUS

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MZF·February 24, 2011

    LIFESHIELD FILTER SOLUSET

    FDA Adverse Event
    Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FPB·February 18, 2008

    EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 29, 2023

    ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 4cm; product code/end item #000846; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.

    FDA Recall
    Terminated ·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007

    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 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 Model 91390 when employing the Spacelabs Command Module, consist of ECU, 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. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 28, 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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012