510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1687
Chemistry
370
Dental
1347
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2204
General Hospital
2052
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
472
Neurology
975
Obstetrics & Gynecology
437
Ophthalmic
279
Orthopedic
2974
Pathology
52
Physical Medicine
515
Radiology
2463
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
396
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
222
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Pacific Device, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Pacific Device, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1990
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pacific Device, Inc.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 05, 1997
VITALMIX PLUS EMPTY I.V. CONTAINER
K972464
·
KPE
General Hospital
·
127d
Cleared
Jul 02, 1993
TRANSFER SET
K923782
·
LHI
General Hospital
·
339d
Cleared
Aug 28, 1991
INTRAVASCULAR ADMINISTRATION SETS
K912860
·
FPA
General Hospital
·
62d
Cleared
Jul 02, 1990
VITALMIX (SET & BAG)
K902482
·
LHI
General Hospital
·
28d
Filters
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5
General Hospital
4
Anesthesiology
1