9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 Diascreen liquid urine control is a synthetic control designed to react with commercial urine dipsticks to register listed responses on color reagent pads. It is intended for use in a clinical laboratory as a urine control for qualitative procedures used in chemical determinations. The control is intended to be used exactly as if it were a patient sample to assist in the assessment of the listed analytical procedures.
FDA Enforcement
Class II
·Terminated·Assuramed·September 25, 2013
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·February 25, 2026
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·December 13, 2023
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·December 13, 2023
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·December 13, 2023
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
FDA Enforcement
Class II
·Terminated·AURIS HEALTH INC·November 27, 2019
MONARCH Bronchoscope. Model Number: MBR-000211-B
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·November 26, 2025