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

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    PRO-FEMUR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040008775·Zirlux 16+ A3.5 89x17x20

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0120010·Screwdriver, Tower Tab, Cannulated

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0120010·Draw Rod, Universal Assembly

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521012091D0·12 x 90 mm SI Implant with HA Coating

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120110·Assembly, Screwdriver, Polyaxial, Cannulated, L...

    ITI DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    EEG WITH VIDEO, MODEL EX-NW

    FDA 510(k)
    FDA Class 2 ·Neurology

    LEVEL 1®HOTLINE® 3 BLOOD AND FLUID WARMER

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BSB·March 22, 2019

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 5, 2022

    HOTLINE® 3 FLUID WARMER

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LGZ·May 15, 2018

    MOTO PARTIAL KNEE 02.18.002LM ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·March 14, 2024

    LEVEL 1® HOTLINE® BLOOD AND FLUID WARMER

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, ASD, INC.·Product code LGZ·June 12, 2018

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 14, 2007

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 20, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 4, 2011

    D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR W/ INTEGRATED RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·November 15, 2018

    Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024