BEUDAMED
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    Ami HTX.

    FDA Enforcement
    Class II ·Ongoing·Spectral Instruments Inc·June 25, 2025

    Lago X

    FDA Enforcement
    Class II ·Ongoing·Spectral Instruments Inc·June 25, 2025

    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 4, 2024

    Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.

    FDA Enforcement
    Class II ·Ongoing·IMRIS Imaging Inc·January 14, 2026

    CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·March 21, 2018

    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.

    FDA Enforcement
    Class II ·Ongoing·IN MY BATHROOM LLC·October 12, 2022

    IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014

    FDA Enforcement
    Class I ·Ongoing·ICU Medical, Inc.·October 29, 2025

    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

    Philips C9-4 Ultrasound Transducer

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

    Philips L17-5 Ultrasound Transducer

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