510k
Database
Specialties
Anesthesiology
508
Cardiovascular
1578
Chemistry
355
Dental
1267
Ear, Nose, Throat
233
Gastroenterology & Urology
918
General & Plastic Surgery
2100
General Hospital
1816
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
446
Neurology
921
Obstetrics & Gynecology
419
Ophthalmic
265
Orthopedic
2674
Pathology
49
Physical Medicine
504
Radiology
2287
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
370
LLZ
System, Image Processing,...
355
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
291
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
250
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Impact Instrumentation, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Impact Instrumentation, Inc. - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 1981
27
Total
27
Cleared
0
Denied
FDA 510(k) Regulatory Record - Impact Instrumentation, Inc.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 05, 1985
IMPACT TURBO CATH
K851611
·
JOL
General Hospital
·
57d
Cleared
Mar 11, 1985
IMPACT 901 SERIES PORT-A-WALL
K850671
·
FOX
General Hospital
·
19d
Cleared
Mar 12, 1982
IMPACT, MODEL 310
K820424
·
GCX
General Hospital
·
24d
Cleared
Mar 02, 1982
IMPACT, MODEL 303
K820337
·
GCX
General Hospital
·
22d
Filters
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27
Anesthesiology
15
General & Plastic Surgery
8
General Hospital
4