BEUDAMED
    757 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.

    FDA Enforcement
    Class II ·Terminated·Ziemer Usa Inc·January 29, 2014

    Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 29, 2025

    BD Vacutainer Urine Collection Cups, Cat. No. 364941

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 28, 2018

    BD Vacutainer Specimen Collection Cups, Cat. No. 364975

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 28, 2018

    Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Terminated·Medtest Holdings, Inc.·June 21, 2017

    KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 28, 2018

    KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 28, 2018

    Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·January 12, 2022

    Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availability. Under conditions of hypoxia, the level of EPO in the circulation increases and this leads to increased production of red blood cells.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 12, 2025

    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·September 6, 2017

    Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538

    FDA Enforcement
    Class II ·Terminated·ConBio, a CynoSure Company·July 3, 2013