BEUDAMED
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    Endoscope Model EI-740D/S

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Dilator, Vascular, acc. Garrett 35cm 1.0mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034047514·Dilator, Vascular, acc. Garrett 35cm 1...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706527·Converse (Maliniac) Nasal Retractor 4-1/4" (10....

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123202935·TUBE OCCLUDING FCPS 8 W/GRD

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·October 18, 2002

    EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

    FDA 510(k)
    FDA Class 2 ·Neurology

    PUMP MMT-508UT EA INSULIN TL EN US

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·October 20, 2008

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·August 12, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·July 3, 2013

    Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·October 6, 2021

    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)

    FDA Enforcement
    Class II ·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014