Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in DenmarkLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of AnalogicLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list B-K Medical with 9 device recalls and 7 510(k) clearances. The most recent is a device recall dated Oct 9, 2025: Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imagin….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 9, 2025 | Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, UltrasonicClass II · GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately | Device recalls |
| Oct 9, 2025 | bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, UltrasonicClass II · GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately | Device recalls |
| Oct 9, 2025 | UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, UltrasonicClass II · GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately | Device recalls |
| Oct 9, 2025 | 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 50Class II · GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately | Device recalls |
| Oct 9, 2025 | bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, UltrasonicClass II · GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately | Device recalls |
| Oct 9, 2025 | bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, UltrasonicClass II · GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately | Device recalls |
| Sep 4, 2024 | bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery opClass II · The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential fo | Device recalls |
| Nov 30, 2023 | bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.Class II · An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. | Device recalls |
| Jan 14, 2005 | ULTRASOUND SCANNER MINI FOCUS, MODEL 1402K043554 · IYN | 510(k) clearances |
| Jan 13, 2005 | ULTRASOUND SCANNER PRO FOCUS, MODEL 2202K043524 · IYN | 510(k) clearances |
| Jan 17, 2003 | ULTRASOUND SCANNER, TYPE 2400K024236 · IYN | 510(k) clearances |
| Nov 1, 2002 | ULTRASOUND SCANNER, TYPE 1101K023457 · IYO | 510(k) clearances |
| Jun 8, 2001 | ULTRASOUND SCANNER, TYPE 2102K011417 · IYO | 510(k) clearances |
| Apr 3, 2001 | ULTRASOUND SCANNER TYPE 2102K003986 · IYN | 510(k) clearances |
| Feb 7, 2001 | ULTRASOUND SCANNER TYPE 2101K003041 · IYO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
