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.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 03, 2021
WoundExpress
K211200
·
JOW
Cardiovascular
·
134d
Cleared
Sep 06, 2019
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
K183574
·
DPW
Cardiovascular
·
259d
Cleared
Apr 04, 2016
Hydroven 12, Hydroven 12 Garments
K152228
·
JOW
Cardiovascular
·
241d
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8
Obstetrics & Gynecology
4
Cardiovascular
3
Anesthesiology
1