6 results
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14ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
FDA Enforcement
Class II
·Terminated·SA3, LLC·April 13, 2022
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
FDA Enforcement
Class II
·Ongoing·Telcare, LLC·March 12, 2025
a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
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