BEUDAMED
    83 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400

    FDA Enforcement
    Class II ·Ongoing·Draeger Medical, Inc.·October 20, 2021

    Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA2110X15B IN2100X15B IN2100X19 IN2110X15B IT2100X21B IT2110X21B JP2100X16B JP2110X16B KR2110X15B LA2100X15B LA2110X15B ND2110X15B RDE2100X13B RDE2110X13B RDS2110X11B RIN2100X15B RIN2110X15B RJP2100X16B RJP2110X16B UDS2110X11B

    FDA Enforcement
    Class II ·Ongoing·Philips Respironics, Inc.·January 10, 2024

    Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·April 10, 2024

    Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·April 10, 2024

    Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·April 10, 2024

    Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiopulmonary Gmbh·August 6, 2025

    Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts

    FDA Enforcement
    Class II ·Ongoing·Human Care Hc Sweden Ab·April 17, 2024

    KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011

    FDA Enforcement
    Class II ·Ongoing·Keystone Industries·January 10, 2024

    Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006

    FDA Enforcement
    Class II ·Ongoing·Belmont Instrument LLC·February 12, 2025

    Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS

    FDA Enforcement
    Class II ·Ongoing·Philips North America LLC·April 13, 2022

    Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507

    FDA Enforcement
    Class II ·Ongoing·Stryker Medical Division of Stryker Corporation·July 19, 2023

    Osteosynthesis Compression Staple EasyClip

    FDA Enforcement
    Class II ·Ongoing·Stryker GmbH·November 25, 2020

    Alinity ci Level Sensor, Bulk Solution

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019

    ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·June 3, 2020

    Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019

    Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019

    Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.

    FDA Enforcement
    Class II ·Ongoing·Macherey Nagel Gmbh & Co. Kg·May 22, 2024

    Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614

    FDA Enforcement
    Class II ·Ongoing·Stryker Leibinger GmbH & Co. KG·May 15, 2024

    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

    FDA Enforcement
    Class II ·Ongoing·Stryker Leibinger GmbH & Co. KG·March 15, 2023

    8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.

    FDA Enforcement
    Class II ·Ongoing·Stryker Leibinger GmbH & Co. KG·May 29, 2024