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    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14; 5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04; 6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11; 7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12; 8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02; 9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88 10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·August 8, 2018

    A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended

    FDA Enforcement
    Class II ·Ongoing·Genicon, Inc.·November 11, 2020

    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

    IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

    FDA Enforcement
    Class III ·Terminated·Iris Diagnostics·August 8, 2012

    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

    Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

    FDA Enforcement
    Class II ·Ongoing·Brasseler USA I Lp·February 14, 2024

    BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.

    FDA Enforcement
    Class II ·Terminated·Brasseler USA I Lp·December 11, 2019

    Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.

    FDA Enforcement
    Class II ·Terminated·Brasseler USA I Lp·February 5, 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

    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