510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1666
Chemistry
362
Dental
1334
Ear, Nose, Throat
245
Gastroenterology & Urology
963
General & Plastic Surgery
2185
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
964
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2884
Pathology
52
Physical Medicine
515
Radiology
2431
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
384
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
352
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Puritas Health Care, Inc.
Medical Device Manufacturer
·
US , Brookfield , CT
Puritas Health Care, Inc. - FDA 510(k) Cleared Devices
24 submissions
·
22 cleared
·
Since 1991
24
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Puritas Health Care, Inc.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 07, 1994
URINARY DRAINAGE BAG
K935557
·
KNX
Gastroenterology & Urology
·
110d
Cleared
Dec 17, 1993
URINE METER
K935578
·
EXR
Gastroenterology & Urology
·
29d
Filters
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24
General Hospital
12
Anesthesiology
5
General & Plastic Surgery
3
Cardiovascular
2
Gastroenterology & Urology
2