510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1338
Ear, Nose, Throat
249
Gastroenterology & Urology
974
General & Plastic Surgery
2194
General Hospital
2047
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
279
Orthopedic
2937
Pathology
52
Physical Medicine
515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Medcomp (Medical Components, Inc.)
Medical Device Manufacturer
·
US , Harleysville , PA
Medcomp (Medical Components, Inc.) - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2013
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medcomp (Medical Components, Inc.)
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 26, 2017
Celerity ECG Cable Accessory Pack
K171931
·
LJS
General Hospital
·
120d
Cleared
Apr 26, 2017
Pro-Lock CT Safety Infusion Set
K162271
·
PTI
General Hospital
·
257d
Cleared
Jul 08, 2014
CT MIDLINE
K141151
·
LJS
General Hospital
·
64d
Cleared
Jun 13, 2014
CELERITY SYSYEM
K140799
·
LJS
General Hospital
·
74d
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6
General Hospital
4
Cardiovascular
2