510k
Database
Specialties
Anesthesiology
131
Cardiovascular
566
Chemistry
162
Dental
310
Ear, Nose, Throat
68
Gastroenterology & Urology
286
General & Plastic Surgery
512
General Hospital
370
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1288
Pathology
18
Physical Medicine
85
Radiology
866
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Resmed Pty , Ltd.
Medical Device Manufacturer
·
AU , Bella Vista
Resmed Pty , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Resmed Pty , Ltd.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 23, 2026
Mariana Minerva
K251661
·
MNS
Anesthesiology
·
269d
Cleared
May 19, 2025
AirFit F20 Mask System
K242547
·
BZD
Anesthesiology
·
265d
Cleared
Dec 18, 2020
S10 Kirra
K203126
·
BZD
Anesthesiology
·
60d
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3
Anesthesiology
3