BEUDAMED
    53 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400

    FDA Enforcement
    Class II ·Terminated·Draeger Medical, Inc.·April 13, 2022

    Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537 Compress Device Centering Sleeve 15mm 178541 Compress Device Centering Sleeve 19mm 178545 Compress Device Centering Sleeve 23mm 178544 Compress Device Centering Sleeve 22mm 178738 Compress Device Centering Sleeve 28mm 178542 Compress Device Centering Sleeve 20mm 32-481123 Compress Instrument Drill For Anti-Rotation Pin 178757 Mini Taper Spindle, 400 lbs, Extra Small 178758 Mini Taper Spindle, 600 lbs, Extra Small 178759 Mini Taper Spindle, 800 lbs, Extra Small 178787 Short Mini Taper Spindle, 400 lbs, Extra Small 178788 Short Mini Taper Spindle, 600 lbs, Extra Small 178789 Short Mini Taper Spindle, 800 lbs, Extra Small

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 26, 2018

    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400

    FDA Enforcement
    Class II ·Ongoing·Draeger Medical, Inc.·October 20, 2021

    Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·January 15, 2014

    Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)

    FDA Enforcement
    Class II ·Terminated·Advanced Back Technologies, Inc.·June 17, 2015

    Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)

    FDA Enforcement
    Class II ·Terminated·Advanced Back Technologies, Inc.·June 17, 2015

    PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

    FDA Enforcement
    Class II ·Terminated·Handicare Usa Inc·October 18, 2017

    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine Inc.·June 14, 2017

    Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS

    FDA Enforcement
    Class II ·Terminated·Oakworks Inc·June 15, 2022

    Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), ¿ 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)

    FDA Enforcement
    Class II ·Terminated·Laerdal Medical Corporation·April 26, 2017

    PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

    FDA Enforcement
    Class II ·Terminated·Oakworks Inc·June 15, 2022

    Handicare P600 Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.

    FDA Enforcement
    Class II ·Terminated·Handicare Usa Inc·August 29, 2018

    A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.

    FDA Enforcement
    Class II ·Terminated·ErgoSafe Products, LLC (DBA) Prism Medical·March 15, 2017

    Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.

    FDA Enforcement
    Class II ·Terminated·Handicare Usa Inc·August 29, 2018

    Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator

    FDA Enforcement
    Class II ·Terminated·Philips North America LLC·September 15, 2021

    Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts

    FDA Enforcement
    Class II ·Ongoing·Human Care Hc Sweden Ab·April 17, 2024

    Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.

    FDA Enforcement
    Class II ·Terminated·ErgoSafe Products, LLC (DBA) Prism Medical·November 25, 2015

    Hill-Rom Progressa Bed System

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 23, 2022

    Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.

    FDA Enforcement
    Class II ·Terminated·Central Purchasing LLC DBA Harbor Freight Tools·April 16, 2014

    AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).

    FDA Enforcement
    Class II ·Terminated·Mobius Imaging, LLC·March 7, 2018