Vital Scientific N.V.
Vital Scientific N.V. holds FDA 510(k) medical device clearances, first cleared 1998, most recent 2002, with 8 FDA device recalls on record.
Top product codes for Vital Scientific N.V.
FDA recalls by Vital Scientific N.V.
- Z-0547-2020 — V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
- Z-0038-2020 — V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
- Z-2558-2019 — V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
- Z-0158-2020 — Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
- Z-0154-2020 — Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
- Z-0156-2020 — V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
- Z-0155-2020 — Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
- Z-0157-2020 — Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Vital Scientific N.V.
- K022021 — VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
- K021976 — FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
- K022046 — VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
- K020840 — VITAL SCIENTIFIC PT WITH CALCIUM
- K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA
Data sourced from openFDA. This site is unofficial and independent of the FDA.