510k
Database
Specialties
Anesthesiology
471
Cardiovascular
1417
Chemistry
334
Dental
1119
Ear, Nose, Throat
209
Gastroenterology & Urology
836
General & Plastic Surgery
1872
General Hospital
1376
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
424
Neurology
807
Obstetrics & Gynecology
354
Ophthalmic
234
Orthopedic
2467
Pathology
48
Physical Medicine
429
Radiology
2045
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
303
GEI
Electrosurgical, Cutting &...
258
QIH
Automated Radiological Image...
255
LZA
Polymer Patient Examination Glove
252
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Hpi, Inc.
Medical Device Manufacturer
·
US , Newton Centre , MA
Hpi, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1990
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hpi, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 07, 1991
SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
K904878
·
IWP
Radiology
·
128d
Cleared
Dec 03, 1990
HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES
K905086
·
IWP
Radiology
·
19d
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6
General Hospital
4
Radiology
2