7 results · 8ms · Sources: EU EUDAMED, US FDA

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Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

FDA Enforcement
Class II ·Terminated·Viterion TeleHealthcare Llc·February 20, 2013

PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corp.·July 6, 2016

Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

FDA Enforcement
Class II ·Terminated·Arrow International Inc·June 14, 2017

Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

FDA Enforcement
Class II ·Terminated·Viterion TeleHealthcare Llc·February 20, 2013

Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

FDA Enforcement
Class II ·Terminated·Viterion TeleHealthcare Llc·February 20, 2013

BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

FDA Enforcement
Class II ·Terminated·B-K Medical A/S·August 10, 2016

Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes

FDA Enforcement
Class II ·Terminated·Arrow International Inc·October 7, 2015