B-K Medical Aps is one of 86 FDA 510(k) medical device manufacturers from Denmark in the dataset, ranked by real submission volume.
B-K Medical Aps - FDA 510(k) Cleared Devices
Recent clearances: ULTRASOUND SCANNER SYSTEM BK2300, ULTRASOUND SCANNER FLEX FOCUS 1202, ULTRASOUND SCANNER PRO FOCUS 2202
11
Total
11
Cleared
0
Denied
B-K Medical Aps has 11 FDA 510(k) cleared radiology devices. Based in Herlev, DK.
Historical record: 11 cleared submissions from 2007 to 2014.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - B-K Medical Aps
11 devices
Cleared
May 30, 2014
ULTRASOUND SCANNER SYSTEM BK2300
Radiology
100d
Cleared
Jan 10, 2014
ULTRASOUND SCANNER FLEX FOCUS 1202
Radiology
168d
Cleared
Jan 10, 2014
ULTRASOUND SCANNER PRO FOCUS 2202
Radiology
165d
Cleared
Jan 07, 2014
ULTRASOUND SCANNER FLEX FOCUS 1202
Radiology
132d
Cleared
Jan 06, 2014
ULTRASOUND SCANNER PRO FOCUS 2202
Radiology
131d
Cleared
Feb 13, 2013
ULTRASOUND SCANNER FLEX FOCUS
Radiology
118d
Cleared
Dec 16, 2011
PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202
Radiology
623d
Cleared
Feb 02, 2009
NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336,...
Radiology
53d
Cleared
Jul 22, 2008
BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
Gastroenterology & Urology
71d
Cleared
May 23, 2008
ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
Radiology
30d
Cleared
Mar 05, 2007
ULTRASOUND SCANNER PROFOCUS, MODEL 2202
Radiology
56d