510k
Database
Specialties
Anesthesiology
440
Cardiovascular
1343
Chemistry
331
Dental
1036
Ear, Nose, Throat
192
Gastroenterology & Urology
796
General & Plastic Surgery
1757
General Hospital
1168
Hematology
118
Immunology
84
Medical Genetics
7
Microbiology
414
Neurology
751
Obstetrics & Gynecology
331
Ophthalmic
205
Orthopedic
2401
Pathology
44
Physical Medicine
402
Radiology
1942
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
287
LLZ
System, Image Processing,...
277
GEI
Electrosurgical, Cutting &...
249
QIH
Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
237
HRS
Plate, Fixation, Bone
234
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
190
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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New Business Development, LLC
Medical Device Manufacturer
·
US , Woodstock , GA
New Business Development, LLC - FDA 510(k) Cleared Devices
4 submissions
·
3 cleared
·
Since 2002
4
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - New Business Development, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 15, 2007
PHENIX VERTEBRAL BODY REPLACEMENT
K072029
·
MQP
Orthopedic
·
83d
Cleared
Oct 04, 2002
NBD CEMENT RESTRICTOR DEVICE
K021788
·
JDK
Orthopedic
·
126d
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4
Orthopedic
2
Neurology
2