510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1672
Chemistry
362
Dental
1336
Ear, Nose, Throat
245
Gastroenterology & Urology
967
General & Plastic Surgery
2190
General Hospital
2045
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2910
Pathology
52
Physical Medicine
515
Radiology
2433
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 &...
302
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...
219
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Concord/Portex
Medical Device Manufacturer
·
US , Keene , NH
Concord/Portex - FDA 510(k) Cleared Devices
23 submissions
·
20 cleared
·
Since 1989
23
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Concord/Portex
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 12, 1992
VACU-PRO
K922445
·
JKA
Chemistry
·
82d
Cleared
Aug 26, 1991
NEW-VENT
K911809
·
JKA
Chemistry
·
125d
Cleared
Jun 21, 1991
SYRINGE TIP CAP
K911638
·
JKA
Chemistry
·
71d
Filters
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23
Anesthesiology
14
General Hospital
4
Chemistry
3
Dental
1
Obstetrics & Gynecology
1