BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179

    FDA Enforcement
    Class II ·Terminated·Diagnos Inc·April 6, 2022

    Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

    FDA Enforcement
    Class II ·Terminated·Northgate Technologies, Inc.·March 3, 2021

    EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).

    FDA Enforcement
    Class II ·Terminated·Edan Diagnostics·August 17, 2016

    LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.

    FDA Enforcement
    Class II ·Ongoing·Linkbio Corp.·April 22, 2026

    CS100 IABP. Software Version CS100 IABP Q.01.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·March 11, 2026

    CS300 IABP. Software Version CS300 IABP C.01.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·March 11, 2026

    Cardiosave Rescue. Intra-Aortic Balloon Pump system.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·December 17, 2025

    Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·December 17, 2025

    NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·September 10, 2025

    Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.

    FDA Enforcement
    Class II ·Ongoing·Volcano Corp·August 6, 2025

    Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·July 16, 2025

    Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·June 25, 2025

    Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.

    FDA Enforcement
    Class II ·Ongoing·Meddev Corp·May 21, 2025

    Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight, 1.2 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.

    FDA Enforcement
    Class II ·Ongoing·Meddev Corp·May 21, 2025

    Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

    FDA Enforcement
    Class II ·Terminated·Volcano Corp·June 22, 2022

    MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·November 13, 2024

    BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/Catalog Number: 320551

    FDA Enforcement
    Class II ·Ongoing·Embecta Corp.·July 31, 2024

    9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·July 17, 2024

    Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·August 28, 2024

    NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2

    FDA Enforcement
    Class II ·Ongoing·NovaSignal Corp.·July 3, 2024