B-K Medical A/S
B-K Medical A/S holds FDA 510(k) medical device clearances, first cleared 1995, most recent 2005, with 9 FDA device recalls on record.
Name variants for B-K Medical A/S
as filed with FDA- B-K Medical A/S
- B & K Medical A/S
Top product codes for B-K Medical A/S
FDA recalls by B-K Medical A/S
- Z-0437-2026 — UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
- Z-0436-2026 — Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
- Z-0440-2026 — bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
- Z-0435-2026 — 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
- Z-0438-2026 — bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
- Z-0439-2026 — bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
- Z-0136-2025 — bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
- Z-0813-2024 — bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
- Z-2325-2016 — 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
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 B-K Medical A/S
- K043554 — ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
- K043524 — ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
- K024236 — ULTRASOUND SCANNER, TYPE 2400
- K023457 — ULTRASOUND SCANNER, TYPE 1101
- K011417 — ULTRASOUND SCANNER, TYPE 2102
- K003986 — ULTRASOUND SCANNER TYPE 2102
- K003041 — ULTRASOUND SCANNER TYPE 2101
- K002085 — ULTRASOUND SCANNER, TYPE 1101
- K000567 — ULTRASOUND SCANNER TYPE 2102
- K991937 — ULTRASOUND SCANNER, MODEL TYPE 2101
- K936024 — ULTRASOUND SCANNER 2001
Data sourced from openFDA. This site is unofficial and independent of the FDA.