BEUDAMED
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    SERALYZER URIC ACID REAGENT STRIPS -

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DSQ Alert RNase P Probe Mix ASR 48 rxn

    FDA UDI
    Elitechgroup Mdx LLC·03661540953163·Product Description DSQ Alert® RNase P Probe Mi...

    ACUMED

    FDA UDI
    Acumed LLC·10806378045257·SLIC Screw® Soft Tissue Protector

    TDK HANDPIECES

    FDA 510(k)
    FDA Class 1 ·Dental

    ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·May 8, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 18, 2012

    UNKNOWN DEPUY FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·August 10, 2010

    OFP FLUSHING PUMP

    FDA Adverse Event
    Malfunction ·KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.·Product code FEQ·January 28, 2026

    SMILE DIRECT

    FDA Adverse Event
    Malfunction ·SMILEDIRECTCLUB / ALIGN TECHNOLOGIES INC·Product code NXC·October 8, 2019

    Disposable Water Trap with ''T'' for Ventilator Circuits; product reorder 6090; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

    FDA Recall
    Terminated ·Medex Inc·Product code BYH·July 12, 2004

    Disposable Water Trap with ''Y'' for Ventilator Circuits; product reorder 6091; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

    FDA Recall
    Terminated ·Medex Inc·Product code BYH·July 12, 2004

    IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use Only; Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641

    FDA Recall
    Terminated ·Medex Inc·Product code BZO·July 12, 2004

    Disposable Oxygen Mask & Bag, Adult Non-Rebreathing Mask w/Safety Vent and 84'' Tube; reorder no. 7022; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

    FDA Recall
    Terminated ·Medex Inc·Product code KGB·July 12, 2004

    Ventilator Circuit with ''Y'' & elbow with 2 Water Traps, for use with/compatible with Bennett 7200; product reorder 6072WT; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

    FDA Recall
    Terminated ·Medex Inc·Product code BZO·July 12, 2004

    Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves, w/84'' Tube (3 in 1 mask); reorder no. 7020; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

    FDA Recall
    Terminated ·Medex Inc·Product code KGB·July 12, 2004

    Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEB·January 16, 2024

    Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code DYB·February 23, 2015

    Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code LJE·October 17, 2025

    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FCG·March 31, 2023