BEUDAMED
    44 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    FIRST RESPONSE 2 CT, SKU 902343

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·November 15, 2023

    VERIQUICK PREGNANCY TEST 1CT, SKU 901260

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·November 15, 2023

    CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·November 15, 2023

    FIRST RESPONSE 2 CT, SKU 902343

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    Veriquick Pregnancy Test 2CT, SKU 903756

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)

    FDA Enforcement
    Class II ·Terminated·Reckitt Benckiser LLC·March 1, 2017

    Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025

    Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number DYNDL1159B; 6) SUTURE TRAY, Pack Number DYNDS1064B

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper

    FDA Enforcement
    Class II ·Ongoing·KCI USA, INC.·February 26, 2025

    3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS SYSTEM KIT, AU PRE4001CA PREVENA PLUS SYSTEM KIT, CA PRE4001UK PREVENA PLUS SYSTEM KIT, UK PRE4001US PREVENA PLUS SYSTEM KIT, US PRE4001 PREVENA PLUS SYSTEM KIT PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CM

    FDA Enforcement
    Class II ·Ongoing·KCI USA, INC.·February 26, 2025

    V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

    FDA Enforcement
    Class II ·Ongoing·KCI USA, INC.·December 4, 2024

    PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014