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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    RANDOX RX DAYTONA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193107226·HA PEEK EVOS Straight, ,14mmx10mmx 22mm , BICON...

    ANODYNE Plate System

    FDA UDI
    CORELINK LLC·M7252024014·ANODYNE CERVICAL SCREW - VARIABLE SELF TAPPING...

    Zavation

    FDA UDI
    Zavation LLC·00842166122253·Self Drilling Fixed Screw, 4.0mm x 14mm

    EndoVive

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00813939020250·

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710810240140·Dwyer Calcaneal Guide, 24mm x 14mm

    QUANTA LITE CCP ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    MD 30 COMPACT

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

    AOS ALPHA PLATE, LEFT, 14 HOLE

    FDA Adverse Event
    Injury ·ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·Product code KTW·February 18, 2021

    HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·October 31, 2014

    HOMEPUMP ECLIPSE: 400ML, 100ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW, LLC·Product code MEB·October 31, 2014

    TOTAL ASR FEM IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·March 27, 2013

    VASCUTRAK 2 PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·March 14, 2011

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008

    VARISOFT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 23, 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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018