510k
Database
Specialties
Anesthesiology
506
Cardiovascular
1577
Chemistry
355
Dental
1263
Ear, Nose, Throat
233
Gastroenterology & Urology
911
General & Plastic Surgery
2093
General Hospital
1778
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126
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91
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8
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445
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916
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417
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265
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2672
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49
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502
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2278
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154
Categories
LZA
Polymer Patient Examination Glove
356
LLZ
System, Image Processing,...
348
GEX
Powered Laser Surgical Instrument
346
GEI
Electrosurgical, Cutting &...
290
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
233
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Intersurgical Incorporated
Medical Device Manufacturer
·
US , Liverpool , NY
Intersurgical Incorporated - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2013
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intersurgical Incorporated
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 04, 2014
EXHALATION VALVE
K132143
·
CBP
Anesthesiology
·
328d
Cleared
Mar 14, 2013
FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
K121747
·
BZD
Anesthesiology
·
273d
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3
Anesthesiology
2
General Hospital
1