510k
Database
Specialties
Anesthesiology
491
Cardiovascular
1497
Chemistry
343
Dental
1183
Ear, Nose, Throat
216
Gastroenterology & Urology
860
General & Plastic Surgery
1947
General Hospital
1505
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
435
Neurology
853
Obstetrics & Gynecology
372
Ophthalmic
251
Orthopedic
2570
Pathology
49
Physical Medicine
457
Radiology
2138
Toxicology
149
Categories
GEX
Powered Laser Surgical Instrument
318
LLZ
System, Image Processing,...
316
LZA
Polymer Patient Examination Glove
290
GEI
Electrosurgical, Cutting &...
270
QIH
Automated Radiological Image...
263
IYN
System, Imaging, Pulsed Doppler,...
257
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
213
NHA
Abutment, Implant, Dental,...
200
MAX
Intervertebral Fusion Device...
181
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Intramed Laboratories, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Intramed Laboratories, Inc. - FDA 510(k) Cleared Devices
14 submissions
·
14 cleared
·
Since 1987
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intramed Laboratories, Inc.
Cardiovascular
✕
5
devices
1-5 of 5
Filters
Cleared
Feb 07, 1995
GRAFT THROMBECTOMY INSTRUMENTS
K942457
·
MCW
Cardiovascular
·
259d
Cleared
Feb 10, 1994
VALVULOTOME
K925283
·
MGZ
Cardiovascular
·
478d
Cleared
Jan 18, 1994
ANGIOSCOPE
K934696
·
LYK
Cardiovascular
·
110d
Cleared
Mar 02, 1992
OPTICAL VALVULOTOME
K914385
·
MGZ
Cardiovascular
·
153d
Cleared
Mar 07, 1990
ANGIOSCOPE
K894459
·
LYK
Cardiovascular
·
232d
Filters
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14
Cardiovascular
5
Gastroenterology & Urology
3
Obstetrics & Gynecology
2
Orthopedic
1
Ophthalmic
1
General Hospital
1
General & Plastic Surgery
1