BEUDAMED
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    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023

    Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments

    FDA Enforcement
    Class II ·Ongoing·Straumann USA LLC·May 6, 2026

    Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

    FDA Enforcement
    Class II ·Ongoing·Straumann USA LLC·May 6, 2026

    ReTurn 7500/7500 Aid, transfer

    FDA Enforcement
    Class II ·Terminated·Handicare USA, Inc.·November 2, 2016

    Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF UVT840A g) BRONCHOALVEOLAR LAVAGE PACK, REF DYNDA2369A; h) CENTRAL LINE NEEDLELESS CONNECTOR KIT, REF DYNDC2869B; i) CVC STERILE CAP CHANGE KIT, REF DT20900A; j) DOUBLE VALVE CHANGE KIT, REF DYNDA2660A; k) KIDNEY BIOPSY PACK, REF DYNDH1650; l) PORT ACCESS INFUSION KIT - 0.75IN NEEDLE, REF DYNDC2816C; m) PORT ACCESS KIT, REF EBSI1302A; n) SHORT TERM INFUSAPORT ACCESS KIT, REF DYNDC3188; o) SINGLE VALVE CHANGE KIT, REF DYNDA2659A; p) SUTURE TRAY, REF DYNDS1085A;

    FDA Enforcement
    Class I ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024

    VITROS 5600 Integrated System (New and Refurbished)

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024

    VITROS 3600 Immunodiagnostic System (New and Refurbished)

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024

    Class IV New Era medical laser device

    FDA Enforcement
    Class II ·Ongoing·Inova Lasers LLC·November 25, 2020

    SMV DSX New Line, System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026

    NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

    FDA Enforcement
    Class II ·Ongoing·New Medical Technologies Gmbh·February 12, 2025

    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

    FDA Enforcement
    Class II ·Ongoing·New Medical Technologies Gmbh·February 12, 2025

    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·September 7, 2022

    1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

    FDA Enforcement
    Class II ·Completed·New Standard Device Inc·June 15, 2022

    Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·June 29, 2022

    StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery.

    FDA Enforcement
    Class II ·Terminated·New Star Lasers, Inc.·July 8, 2015

    ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis

    FDA Enforcement
    Class II ·Terminated·New Star Lasers, Inc.·October 12, 2016