510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1611
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2135
General Hospital
1988
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
428
Ophthalmic
272
Orthopedic
2701
Pathology
52
Physical Medicine
514
Radiology
2320
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
368
FXX
Mask, Surgical
354
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
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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Huntleigh Healthcare , Ltd.
Medical Device Manufacturer
·
GB , Cardiff
Huntleigh Healthcare , Ltd. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2006
Official Website
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 19, 2025
Sonicaid Team3
K250777
·
HGM
Obstetrics & Gynecology
·
189d
Cleared
Feb 03, 2025
Sonicaid Team3
K241368
·
HGM
Obstetrics & Gynecology
·
265d
Cleared
Jul 15, 2009
SONICAID FM820 AND FM830 ENCORE
K090285
·
HGM
Obstetrics & Gynecology
·
160d
Cleared
Mar 23, 2006
DOPPLEX CENTRALE
K060230
·
HGM
Obstetrics & Gynecology
·
52d
Filters
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8
Obstetrics & Gynecology
4
Cardiovascular
3
Anesthesiology
1