510k
Database
Specialties
Anesthesiology
130
Cardiovascular
566
Chemistry
162
Dental
309
Ear, Nose, Throat
68
Gastroenterology & Urology
286
General & Plastic Surgery
511
General Hospital
369
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
60
Ophthalmic
49
Orthopedic
1286
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
MAX
Intervertebral Fusion Device...
83
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
80
JAK
System, X-ray, Tomography, Computed
79
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Oxehealth Limited
Medical Device Manufacturer
·
GB , Abingdon
Oxehealth Limited - FDA 510(k) Cleared Devices
6 submissions
·
5 cleared
·
Since 2021
6
Total
5
Cleared
1
Denied
FDA 510(k) cleared devices by Oxehealth Limited
Cardiovascular
✕
5
devices
1-5 of 5
Filters
Cleared
Feb 02, 2026
Vital Signs
K251200
·
QME
Cardiovascular
·
290d
Cleared
Aug 27, 2025
Vital Signs
K243687
·
QME
Cardiovascular
·
271d
Cleared
Apr 29, 2022
Oxehealth Vital Signs
K220899
·
QME
Cardiovascular
·
32d
Cleared
Jul 20, 2021
Vital Signs
K211906
·
QME
Cardiovascular
·
29d
Not Cleared
Mar 26, 2021
Oxehealth Vital Signs
DEN200019
·
QME
Cardiovascular
·
364d
Filters
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6
Cardiovascular
5
Neurology
1