510k
Database
Specialties
Anesthesiology
444
Cardiovascular
1348
Chemistry
331
Dental
1048
Ear, Nose, Throat
193
Gastroenterology & Urology
803
General & Plastic Surgery
1767
General Hospital
1188
Hematology
120
Immunology
84
Medical Genetics
7
Microbiology
418
Neurology
759
Obstetrics & Gynecology
332
Ophthalmic
208
Orthopedic
2413
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44
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405
Radiology
1953
Toxicology
142
Categories
GEX
Powered Laser Surgical Instrument
287
LLZ
System, Image Processing,...
278
GEI
Electrosurgical, Cutting &...
250
QIH
Automated Radiological Image...
248
IYN
System, Imaging, Pulsed Doppler,...
238
HRS
Plate, Fixation, Bone
235
LZA
Polymer Patient Examination Glove
199
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
167
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I.Z.I. Medical Products Corp.
Medical Device Manufacturer
·
US , Owings Mills , MD
I.Z.I. Medical Products Corp. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1996
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - I.Z.I. Medical Products Corp.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 03, 1999
TOPOGRAPHIC IMAGING MARKER
K990242
·
KPR
Radiology
·
37d
Cleared
Mar 03, 1999
TOPOGRAPHIC IMAGING MARKER
K990298
·
KPR
Radiology
·
30d
Cleared
May 05, 1997
SHADOWFORM
K964972
·
KPQ
Radiology
·
144d
Cleared
Aug 07, 1996
TOPOGRAPHIC IMAGING MARKER
K962606
·
JAA
Radiology
·
36d
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4
Radiology
4