BEUDAMED
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    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100550·Caddie, Misc Screws

    REVERSE MEDICAL REFLEX GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN MICROCATHETER

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017

    Corin BiPolar-i

    FDA UDI
    CORIN LTD·05056139234019·Acetabular Trial Ø55

    GUEDEL AIRWAY, SIZE 0, ISO 5.5

    FDA UDI
    Intersurgical Incorporated·05030267050574·GUEDEL AIRWAY, SIZE 0, ISO 5.5

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521110055D0·10 x 55 mm Anodized SI Implant Fully Threaded

    BLOOD PRESSURE METER, MODEL CH-609

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINEAR 3-4

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 19, 2022

    LINEAR 3-6

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 2, 2024

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code IOR·May 13, 2013

    PLUM A+ DRIVER REFUR

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·September 11, 2014

    SYBRONPRO XRT

    FDA Adverse Event
    Injury ·EBI INC.·Product code DZE·June 1, 2011

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 27, 2022

    Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 24, 2024

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025

    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

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024