510k
Database
Specialties
Anesthesiology
392
Cardiovascular
1204
Chemistry
298
Dental
900
Ear, Nose, Throat
169
Gastroenterology & Urology
712
General & Plastic Surgery
1537
General Hospital
915
Hematology
111
Immunology
79
Medical Genetics
3
Microbiology
393
Neurology
665
Obstetrics & Gynecology
286
Ophthalmic
177
Orthopedic
2199
Pathology
42
Physical Medicine
360
Radiology
1764
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
253
LLZ
System, Image Processing,...
232
QIH
Automated Radiological Image...
232
IYN
System, Imaging, Pulsed Doppler,...
221
GEI
Electrosurgical, Cutting &...
218
HRS
Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
150
MAX
Intervertebral Fusion Device...
146
Browse all 339 categories →
Search
Reports
About
Home
B-K Medical Aps
Medical Device Manufacturer
·
DK , Herlev
B-K Medical Aps - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 2007
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - B-K Medical Aps
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
Jul 22, 2008
BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
K081323
·
FCG
Gastroenterology & Urology
·
71d
Filters
Filter by Specialty
All
11
Radiology
10
Gastroenterology & Urology
1