510k
Database
Specialties
Anesthesiology
486
Cardiovascular
1477
Chemistry
342
Dental
1165
Ear, Nose, Throat
216
Gastroenterology & Urology
856
General & Plastic Surgery
1935
General Hospital
1477
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
836
Obstetrics & Gynecology
369
Ophthalmic
250
Orthopedic
2548
Pathology
49
Physical Medicine
454
Radiology
2097
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
315
LLZ
System, Image Processing,...
308
LZA
Polymer Patient Examination Glove
286
GEI
Electrosurgical, Cutting &...
269
QIH
Automated Radiological Image...
259
HRS
Plate, Fixation, Bone
250
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
209
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
177
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Elmed, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Elmed, Inc. - FDA 510(k) Cleared Devices
26 submissions
·
26 cleared
·
Since 1977
26
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - Elmed, Inc.
Obstetrics & Gynecology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 15, 1994
ELMED LBC 50-P
K926517
·
HIN
Obstetrics & Gynecology
·
685d
Cleared
Jan 31, 1991
ELMED PNEUMOMAT DIGITAL
K905417
·
HIF
Obstetrics & Gynecology
·
58d
Cleared
Sep 17, 1979
KOLPOSKOP KP20005
K791279
·
HEX
Obstetrics & Gynecology
·
69d
Filters
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All
26
General & Plastic Surgery
8
Physical Medicine
7
Obstetrics & Gynecology
3
Neurology
3
Cardiovascular
2
Radiology
1
General Hospital
1
Ophthalmic
1