BEUDAMED
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    REPROCESSED ARTHROSCOPIC SHAPERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033442357·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033442340·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033442364·

    INSET I

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 21, 2026

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·February 2, 2026

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 6, 2026

    GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R

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

    HORIZONS INTERNATIONAL POLYPECTOMY SNARES

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

    CRANIAL ACCESS KIT W/TWIST LOCK DRILL GUARD

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORP.·Product code HBF·January 20, 2005

    ION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 20, 2013

    PROXIMATE** SKIN STAPLER 35 WIDE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDT·March 10, 2011

    NA

    FDA Adverse Event
    Injury ·ASCENT HEALTHCARE SOLUTIONS·Product code NLF·March 11, 2008

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020