510k
Database
Specialties
Anesthesiology
492
Cardiovascular
1515
Chemistry
345
Dental
1196
Ear, Nose, Throat
222
Gastroenterology & Urology
874
General & Plastic Surgery
1985
General Hospital
1538
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
437
Neurology
869
Obstetrics & Gynecology
383
Ophthalmic
254
Orthopedic
2599
Pathology
49
Physical Medicine
464
Radiology
2169
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
324
LLZ
System, Image Processing,...
321
LZA
Polymer Patient Examination Glove
297
GEI
Electrosurgical, Cutting &...
276
QIH
Automated Radiological Image...
263
IYN
System, Imaging, Pulsed Doppler,...
260
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
184
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Lake Region Mfg., Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Lake Region Mfg., Inc. - FDA 510(k) Cleared Devices
42 submissions
·
42 cleared
·
Since 1977
42
Total
42
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lake Region Mfg., Inc.
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
May 06, 1986
FASICULATED NAIL
K861365
·
HSB
Orthopedic
·
25d
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42
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34
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7
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