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

    Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens

    FDA Enforcement
    Class II ·Terminated·Medtronic·December 28, 2016

    Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X

    FDA Enforcement
    Class II ·Ongoing·Philips North America·April 3, 2024

    Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essentials Expand Product Number: 867154

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·September 27, 2023

    namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·May 22, 2024

    AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

    FDA Enforcement
    Class II ·Terminated·Avanos Medical, Inc.·June 14, 2023

    AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

    FDA Enforcement
    Class II ·Terminated·Avanos Medical, Inc.·June 14, 2023

    The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 12, 2017

    Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 3, 2014

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Enforcement
    Class II ·Terminated·Water Pik, Inc.·August 15, 2018

    DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 9, 2024

    (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 24, 2024

    3mensio Workstation (Vascular Fenestrated) software

    FDA Enforcement
    Class II ·Ongoing·PIE Medical Imaging B.V.·August 20, 2025

    Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply Model: SCL500RMI1U

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 1, 2024

    Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016