BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S

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

    Trulife

    FDA UDI
    Trulife Limited·00645517612850·ActiveFlow External Breast Form Size 13

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193104508·HA PEEK EVOS Curved, , 13mmx9mmx 30mm , BICONVE...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0130130·Sagittal Bender, Left

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0600130·Tray Insert 3, Cosmolock Deformity

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K0690130·Tray Insert, MIS Lumbar Instruments 2

    MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STRYKER XCEL ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

    PEGASUS PNK 20GA X 1.16IN PRN NON-PVC

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·February 18, 2021

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 3, 2018

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 17, 2013

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 18, 2008

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 19, 2011

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code NGT·November 6, 2020

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018