510k
Database
Specialties
Anesthesiology
510
Cardiovascular
1583
Chemistry
355
Dental
1272
Ear, Nose, Throat
233
Gastroenterology & Urology
922
General & Plastic Surgery
2108
General Hospital
1851
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
925
Obstetrics & Gynecology
420
Ophthalmic
266
Orthopedic
2677
Pathology
50
Physical Medicine
506
Radiology
2289
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
379
LLZ
System, Image Processing,...
356
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
FXX
Mask, Surgical
268
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Aeiomed, Inc.
Medical Device Manufacturer
·
US , Stoughton , WI
Aeiomed, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2004
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aeiomed, Inc.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 13, 2010
MODEL 300157 CPAP SYSTEM
K100121
·
BZD
Anesthesiology
·
179d
Cleared
Feb 08, 2008
REUSABLE HEADREST WITH NASAL SEAL
K072993
·
BZD
Anesthesiology
·
108d
Cleared
Mar 09, 2005
AURA CPAP SYSTEM
K042945
·
BZD
Anesthesiology
·
135d
Cleared
Sep 08, 2004
AURA CPAP PATIENT INTERFACE
K042130
·
BZD
Anesthesiology
·
33d
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Anesthesiology
4