BEUDAMED
    1,025 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii ×

    Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography

    FDA Enforcement
    Class III ·Terminated·Beekley Corporation·June 18, 2014

    a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ2 1" 50YDS Catalog # GL-220. c. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ4 25/8" 50YDS Catalog # GL-222. d. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 5/8"X50YDS Catalog # GL-241. e. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 11/2"X50YDS Catalog # GL-243

    FDA Enforcement
    Class III ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022

    Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500

    FDA Enforcement
    Class III ·Terminated·Teleflex Medical·January 22, 2020

    Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M

    FDA Enforcement
    Class III ·Terminated·Teleflex Medical·January 22, 2020

    Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.

    FDA Enforcement
    Class III ·Terminated·OraSure Technologies, Inc.·September 30, 2020

    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.

    FDA Enforcement
    Class III ·Terminated·Biocare Medical, LLC·June 3, 2015

    Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Heraeus, PALAMIX duo. Material Number: 66057897.

    FDA Enforcement
    Class III ·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026

    Heraeus, PALAMIX uno. Material Number: 66057893.

    FDA Enforcement
    Class III ·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026

    Philips OMNI II TEE Ultrasound Transducer

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

    Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2

    FDA Enforcement
    Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

    Philips OMNI III TEE Ultrasound Transducer

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

    Philips X7-2 Ultrasound Transducer

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

    Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1

    FDA Enforcement
    Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

    Philips S4-1 Ultrasound Transducer

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

    Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

    FDA Enforcement
    Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

    Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

    FDA Enforcement
    Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026