510k
Database
Specialties
Anesthesiology
541
Cardiovascular
1680
Chemistry
364
Dental
1336
Ear, Nose, Throat
245
Gastroenterology & Urology
971
General & Plastic Surgery
2191
General Hospital
2046
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2919
Pathology
52
Physical Medicine
515
Radiology
2436
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
303
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Boston Pacific Medical, Inc.
Medical Device Manufacturer
·
US , Boston , MA
Boston Pacific Medical, Inc. - FDA 510(k) Cleared Devices
11 submissions
·
8 cleared
·
Since 1992
11
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Boston Pacific Medical, Inc.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 07, 1993
4 SURE TM SUCTION CATHETERS & KITS
K921851
·
BSY
Anesthesiology
·
446d
Cleared
Mar 18, 1993
4 SURE TM NASAL OXYGEN CANNULA
K922397
·
CAT
Anesthesiology
·
301d
Cleared
Dec 30, 1992
4 SURE TM ANESTHESIA EXTENSION SET
K924995
·
BSO
Anesthesiology
·
90d
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11
Gastroenterology & Urology
7
Anesthesiology
3
General Hospital
1