BEUDAMED
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    MEDCOMP ASH SPLIT-CATH II

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    APC™ PLUS Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221092984·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL1 14T/...

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221061966·Mini Uni-Twin(TM) Bracket APC(TM) II UL1 14T/5A...

    3M™ Unitek™ Uni-Twin™

    FDA UDI
    3M UNITEK CORPORATION·00652221016058·Mini Uni-Twin(TM) Bracket UL1 14T/5A .018 5/Pk

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450157633·

    SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DENSTAT

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

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·November 29, 2017

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·October 19, 2017

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 31, 2007

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013

    NONE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·February 16, 2011

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014