510k
Database
Specialties
Anesthesiology
484
Cardiovascular
1473
Chemistry
339
Dental
1160
Ear, Nose, Throat
216
Gastroenterology & Urology
851
General & Plastic Surgery
1926
General Hospital
1461
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
831
Obstetrics & Gynecology
367
Ophthalmic
248
Orthopedic
2531
Pathology
49
Physical Medicine
448
Radiology
2085
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
314
LLZ
System, Image Processing,...
307
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
266
QIH
Automated Radiological Image...
257
HRS
Plate, Fixation, Bone
249
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
208
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
174
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Downs Surgical , Ltd.
Medical Device Manufacturer
·
US , Mchenry , IL
Downs Surgical , Ltd. - FDA 510(k) Cleared Devices
60 submissions
·
60 cleared
·
Since 1980
60
Total
60
Cleared
0
Denied
FDA 510(k) Regulatory Record - Downs Surgical , Ltd.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 10, 1981
LEKSELL STEREOACTIC SYSTEM
K811726
·
LHF
Radiology
·
22d
Cleared
Feb 05, 1981
LEKSELL STEREOTACTIC SYSTEM
K802140
·
IWY
Radiology
·
154d
Cleared
Jan 28, 1981
X-RAY STAND & OPERATING CHAIR
K803162
·
IYB
Radiology
·
146d
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All
60
Orthopedic
21
General & Plastic Surgery
17
Neurology
11
Radiology
3
Ear, Nose, Throat
3
Obstetrics & Gynecology
2
Dental
2
Ophthalmic
1