Atlas FDA

B-K Medical A/S

8 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch B-K Medical A/S

RecordFirmDate
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 20 recall (Z-0435-2026)B-K Medical A/S2025-11-06
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, recall (Z-0436-2026)B-K Medical A/S2025-11-06
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Dop recall (Z-0437-2026)B-K Medical A/S2025-11-06
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ul recall (Z-0438-2026)B-K Medical A/S2025-11-06
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ul recall (Z-0439-2026)B-K Medical A/S2025-11-06
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ul recall (Z-0440-2026)B-K Medical A/S2025-11-06
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, recall (Z-0136-2025)B-K Medical A/S2024-10-18
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. recall (Z-0813-2024)B-K Medical A/S2024-01-25

Track B-K Medical A/S automatically

Every clearance here is in the API, with alerts when new ones post.