510k
Database
Specialties
Anesthesiology
510
Cardiovascular
1583
Chemistry
355
Dental
1272
Ear, Nose, Throat
233
Gastroenterology & Urology
922
General & Plastic Surgery
2108
General Hospital
1848
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
925
Obstetrics & Gynecology
420
Ophthalmic
265
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
266
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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Aerogen (Ireland), Ltd.
Medical Device Manufacturer
·
IE , Dangan Galway
Aerogen (Ireland), Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2007
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aerogen (Ireland), Ltd.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 10, 2010
NIVO NEBULIZER SYSTEM
K102240
·
CAF
Anesthesiology
·
93d
Cleared
Oct 23, 2008
AERONEB GO NEBULIZER
K081650
·
CAF
Anesthesiology
·
133d
Cleared
May 07, 2007
AERONEB PROFESSIONAL NEBULIZER SYSTEM
K070642
·
CAF
Anesthesiology
·
60d
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3
Anesthesiology
3