BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113721·CYSTOTOME CURVED 27GA

    R&D Batteries, Inc.

    FDA UDI
    R & D Batteries, Inc.·00810149097133·14.8 Volt 5.8Ah Li-Ion OEM

    M9 Li-ion battery FRU(FDA)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904089621·

    Vdrive System

    FDA UDI
    Stereotaxis, Inc.·M58800100230720·"The Vdrive® system is intended to stabilize, n...

    CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 27, 2025

    GEM SPLT SET Y-EXT BCXCHK 282CM (50EA/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014

    GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014

    GEM SPLT SET Y-EXT BCKCHK 282CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 23, 2014

    GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·November 27, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·February 26, 2013

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 24, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008

    NEXGEN STEMMED PRECOAT TIBIAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER MANUFACTURING B.V.·Product code JWH·July 7, 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

    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