510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
934
General & Plastic Surgery
2142
General Hospital
2009
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
458
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2757
Pathology
52
Physical Medicine
515
Radiology
2354
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
406
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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International Biomedical
Medical Device Manufacturer
·
US , Austin , TX
International Biomedical - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2014
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - International Biomedical
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 10, 2020
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
K193481
·
MRN
Anesthesiology
·
84d
Cleared
Jan 18, 2019
Puffin Lite Infant Resuscitation System
K182956
·
BTL
Anesthesiology
·
86d
Cleared
May 28, 2014
LIFEBORNE INFANT RESUSCITATOR
K140707
·
BTL
Anesthesiology
·
69d
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8
Anesthesiology
3
General Hospital
3
Physical Medicine
2