510k
Database
Specialties
Anesthesiology
505
Cardiovascular
1575
Chemistry
355
Dental
1257
Ear, Nose, Throat
233
Gastroenterology & Urology
910
General & Plastic Surgery
2090
General Hospital
1747
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
444
Neurology
916
Obstetrics & Gynecology
417
Ophthalmic
265
Orthopedic
2672
Pathology
49
Physical Medicine
501
Radiology
2273
Toxicology
154
Categories
LLZ
System, Image Processing,...
347
LZA
Polymer Patient Examination Glove
346
GEX
Powered Laser Surgical Instrument
345
GEI
Electrosurgical, Cutting &...
290
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
222
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Halyard Health, Inc.
Medical Device Manufacturer
·
US , Roswell , GA
Halyard Health, Inc. - FDA 510(k) Cleared Devices
7 submissions
·
6 cleared
·
Since 2015
7
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Halyard Health, Inc.
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 26, 2018
Mic-Key* SF Over-the-Wire Stoma Measuring Device
K173955
·
KNT
Gastroenterology & Urology
·
29d
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7
General Hospital
3
Neurology
2
Anesthesiology
1
Gastroenterology & Urology
1