B & K Medical A/S is one of 106 FDA 510(k) medical device manufacturers from Denmark in the dataset, ranked by real submission volume.
B & K Medical A/S - FDA 510(k) Cleared Devices
Recent clearances: ULTRASOUND SCANNER MINI FOCUS, MODEL 1402, ULTRASOUND SCANNER PRO FOCUS, MODEL 2202, ULTRASOUND SCANNER, TYPE 2400
11
Total
11
Cleared
0
Denied
B & K Medical A/S has 11 FDA 510(k) cleared radiology devices. Based in Dk 2820 Gentofte, DK.
Historical record: 11 cleared submissions from 1995 to 2005.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by B-K Medical A/S as regulatory consultant.
FDA 510(k) Regulatory Record - B & K Medical A/S
11 devices
Cleared
Jan 14, 2005
ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
Radiology
18d
Cleared
Jan 13, 2005
ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
Radiology
24d
Cleared
Jan 17, 2003
ULTRASOUND SCANNER, TYPE 2400
Radiology
25d
Cleared
Nov 01, 2002
ULTRASOUND SCANNER, TYPE 1101
Radiology
17d
Cleared
Jun 08, 2001
ULTRASOUND SCANNER, TYPE 2102
Radiology
30d
Cleared
Apr 03, 2001
ULTRASOUND SCANNER TYPE 2102
Radiology
98d
Cleared
Feb 07, 2001
ULTRASOUND SCANNER TYPE 2101
Radiology
131d
Cleared
Aug 01, 2000
ULTRASOUND SCANNER, TYPE 1101
Radiology
22d
Cleared
Mar 09, 2000
ULTRASOUND SCANNER TYPE 2102
Radiology
16d
Cleared
Jul 30, 1999
ULTRASOUND SCANNER, MODEL TYPE 2101
Radiology
51d
Cleared
Aug 22, 1995
ULTRASOUND SCANNER 2001
Radiology
613d