510k
Database
Specialties
Anesthesiology
505
Cardiovascular
1572
Chemistry
355
Dental
1253
Ear, Nose, Throat
233
Gastroenterology & Urology
910
General & Plastic Surgery
2087
General Hospital
1740
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
444
Neurology
914
Obstetrics & Gynecology
417
Ophthalmic
265
Orthopedic
2666
Pathology
49
Physical Medicine
501
Radiology
2269
Toxicology
154
Categories
LLZ
System, Image Processing,...
347
LZA
Polymer Patient Examination Glove
346
GEX
Powered Laser Surgical Instrument
345
GEI
Electrosurgical, Cutting &...
290
QIH
Automated Radiological Image...
271
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
219
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Atos Medical AB
Medical Device Manufacturer
·
US , Potomac , MD
Atos Medical AB - FDA 510(k) Cleared Devices
15 submissions
·
14 cleared
·
Since 1990
15
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Atos Medical AB
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 12, 2016
ProTrach Dualcare
K151404
·
JOH
Anesthesiology
·
262d
Cleared
May 30, 2008
PROVOX MICRON HME
K072582
·
JOH
Anesthesiology
·
260d
Cleared
Feb 21, 2002
PROVOX HME CASSETTE, MODEL 7240
K014102
·
JOH
Anesthesiology
·
70d
Filters
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All
15
Ear, Nose, Throat
9
General & Plastic Surgery
3
Anesthesiology
3