510k
Database
Specialties
Anesthesiology
338
Cardiovascular
1076
Chemistry
273
Dental
827
Ear, Nose, Throat
149
Gastroenterology & Urology
639
General & Plastic Surgery
1339
General Hospital
778
Hematology
100
Immunology
72
Medical Genetics
1
Microbiology
369
Neurology
591
Obstetrics & Gynecology
249
Ophthalmic
159
Orthopedic
2068
Pathology
40
Physical Medicine
314
Radiology
1601
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
200
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
162
NKB
Thoracolumbosacral Pedicle Screw...
138
MAX
Intervertebral Fusion Device...
138
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Harleco
Medical Device Manufacturer
·
US , Mchenry , IL
Harleco - FDA 510(k) Cleared Devices
116 submissions
·
116 cleared
·
Since 1976
116
Total
116
Cleared
0
Denied
FDA 510(k) Regulatory Record - Harleco
Pathology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 02, 1977
KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP
K771925
·
KES
Pathology
·
19d
Cleared
Aug 22, 1977
HISTOCHEMICAL AFB DEMONSTRATION
K771390
·
ICL
Pathology
·
26d
Filters
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All
116
Chemistry
105
Hematology
7
Pathology
2
Microbiology
1
Immunology
1