BEUDAMED
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    Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902757891·INSTRUMENT 8161214 2PRNG 14MM S STPL TRL

    Symmetry Kocher

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482040218·Symmetry® Forceps, Kocher Hemostatic, Straight,...

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521612140·

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962162699·KOCHER HEMOSTATIC FORCEPS, 5 5/8", STR

    GUARDIAN CONNECTION

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

    AQUARIUSAPS SERVER

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 13, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    SOLETRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·September 15, 2008

    DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·December 21, 2016

    ACCESS ACCUTNI REAGENT

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·September 15, 2016

    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·March 23, 2018

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026