BEUDAMED
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    POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Pro Advantage

    FDA UDI
    NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P01355443·Pro Advantage Pouch 3.5 X 5.25

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010091093·TENDON STRIPPER, SLOTTED, 5 MM ...

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033510711·

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795134264·3.5mm x 54mm, Threaded Peg, Ti

    HARDYDISK TRIMETHOPRIM 5MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 15, 2025

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·March 20, 2013

    DEFINIUM 8000

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code KPR·February 3, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

    TENDON STRIPPER,SLOTTED

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code LXH·May 30, 2017

    EDWARDS ESHEATH INTRODUCER SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021

    EDWARDS TF SHEATH UNKNOWN

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021

    TENDON STRIPPER SLOTTED

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code LXH·July 23, 2019

    Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554 Orthopedic Manual Surgical Instrument

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code LXH·July 7, 2011

    TENDON STRIPPER SLOTTED

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code LXH·March 29, 2020

    Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014