510k
Database
Specialties
Anesthesiology
522
Cardiovascular
1608
Chemistry
356
Dental
1300
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2131
General Hospital
1973
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
940
Obstetrics & Gynecology
426
Ophthalmic
271
Orthopedic
2696
Pathology
52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
402
LLZ
System, Image Processing,...
367
GEX
Powered Laser Surgical Instrument
350
FXX
Mask, Surgical
346
GEI
Electrosurgical, Cutting &...
294
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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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) Regulatory Record - 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