510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2177
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
960
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2846
Pathology
52
Physical Medicine
515
Radiology
2417
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Arc Medical, Inc.
Medical Device Manufacturer
·
US , Clarkston , GA
Arc Medical, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1993
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Arc Medical, Inc.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 27, 2009
THERMOFLO HCH, THERMOFLO FILTER
K090738
·
CAH
General Hospital
·
129d
Cleared
Apr 13, 2007
FILTERFLO HEPA
K063125
·
CAH
General Hospital
·
182d
Cleared
Dec 20, 2001
FILTERFLO H
K011212
·
CAH
General Hospital
·
244d
Cleared
Aug 14, 1998
CIRCUIT GUARD
K982239
·
CAH
General Hospital
·
52d
Filters
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6
General Hospital
4
Anesthesiology
2