BEUDAMED
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    Filters Classification: Class Ii ×

    Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012

    FDA Enforcement
    Class II ·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023

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

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

    RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·December 31, 2014

    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·May 22, 2013

    iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·September 2, 2015

    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

    Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 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

    Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

    FDA Enforcement
    Class II ·Terminated·Irvine Biomedical Inc, a St. Jude Medical Co.·September 30, 2020

    Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

    FDA Enforcement
    Class II ·Terminated·Irvine Biomedical Inc, a St. Jude Medical Co.·September 30, 2020

    11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms

    FDA Enforcement
    Class II ·Terminated·Ii - Vi Incorporated·June 13, 2018