510k
Database
Specialties
Anesthesiology
531
Cardiovascular
1642
Chemistry
359
Dental
1314
Ear, Nose, Throat
242
Gastroenterology & Urology
953
General & Plastic Surgery
2165
General Hospital
2031
Hematology
126
Immunology
97
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8
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462
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950
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433
Ophthalmic
274
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2812
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52
Physical Medicine
515
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2386
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
378
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
298
IYN
System, Imaging, Pulsed Doppler,...
280
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
224
MAX
Intervertebral Fusion Device...
208
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Kirk Specialty Systems
Medical Device Manufacturer
·
US , Carrollton , TX
Kirk Specialty Systems - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1993
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kirk Specialty Systems
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 08, 1996
ESOPHAGEAL INTUBATION DETECTOR
K962098
·
BTR
Anesthesiology
·
132d
Cleared
Aug 28, 1995
CAPNO-FLO REGULATOR, CAPNO-FLO
K952512
·
BTM
Anesthesiology
·
90d
Cleared
Feb 24, 1995
CAPNO-FLO(TM) REGULATOR
K945822
·
CBP
Anesthesiology
·
87d
Cleared
Oct 06, 1993
CAPNO-FLO
K933626
·
BTM
Anesthesiology
·
82d
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4
Anesthesiology
4