510k
Database
Specialties
Anesthesiology
524
Cardiovascular
1611
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2135
General Hospital
1988
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
941
Obstetrics & Gynecology
427
Ophthalmic
272
Orthopedic
2701
Pathology
52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
367
FXX
Mask, Surgical
354
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Engineered Medical Systems
Medical Device Manufacturer
·
US , Indianapolis , IN
Engineered Medical Systems - FDA 510(k) Cleared Devices
22 submissions
·
22 cleared
·
Since 1987
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Engineered Medical Systems
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 19, 2002
EMS ELECTROSTATIC FLITER AND HME COMBINATION
K013122
·
CAH
General Hospital
·
212d
Cleared
Mar 14, 2002
EMS HEPA FILTER AND HME COMBINATIONS
K013089
·
CAH
General Hospital
·
178d
Filters
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22
Anesthesiology
19
General Hospital
2
Gastroenterology & Urology
1