510k
Database
Specialties
Anesthesiology
450
Cardiovascular
1369
Chemistry
334
Dental
1058
Ear, Nose, Throat
194
Gastroenterology & Urology
810
General & Plastic Surgery
1784
General Hospital
1218
Hematology
121
Immunology
84
Medical Genetics
7
Microbiology
420
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767
Obstetrics & Gynecology
336
Ophthalmic
212
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2428
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44
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411
Radiology
1981
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
290
LLZ
System, Image Processing,...
284
GEI
Electrosurgical, Cutting &...
253
QIH
Automated Radiological Image...
251
IYN
System, Imaging, Pulsed Doppler,...
241
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
207
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
168
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International Regulatory Consultants
Medical Device Manufacturer
·
IL , Efrat, Israel
International Regulatory Consultants - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1994
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - International Regulatory Consultants
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 06, 1996
SHIFA STERILE DISPOSABLE SYRINGES
K962614
·
FMF
General Hospital
·
65d
Cleared
Aug 18, 1995
DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES
K950012
·
FMI
General Hospital
·
227d
Cleared
Oct 19, 1994
MEMOTHERM 10 BABY THERMOMETER
K935280
·
FLL
General Hospital
·
350d
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5
General Hospital
3
Radiology
1
Gastroenterology & Urology
1