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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 6 of 6 Results
510(K) Number: K223830
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Product Description
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bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. 2 01/25/2024 FEI # 3003705156
B-K Medical A/S
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic 2 11/06/2025 FEI # 3003705156
B-K Medical A/S
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic 2 11/06/2025 FEI # 3003705156
B-K Medical A/S
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #23... 2 10/18/2024 FEI # 3003705156
B-K Medical A/S
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic 2 11/06/2025 FEI # 3003705156
B-K Medical A/S
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultr... 2 11/06/2025 FEI # 3003705156
B-K Medical A/S
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