510k
Database
Specialties
Anesthesiology
483
Cardiovascular
1461
Chemistry
339
Dental
1159
Ear, Nose, Throat
215
Gastroenterology & Urology
849
General & Plastic Surgery
1915
General Hospital
1455
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
826
Obstetrics & Gynecology
364
Ophthalmic
242
Orthopedic
2514
Pathology
49
Physical Medicine
443
Radiology
2083
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
313
LLZ
System, Image Processing,...
307
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
263
QIH
Automated Radiological Image...
257
IYN
System, Imaging, Pulsed Doppler,...
247
HRS
Plate, Fixation, Bone
247
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Randwal Instrument Co., Inc.
Medical Device Manufacturer
·
US , Southbridge , MA
Randwal Instrument Co., Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1983
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Randwal Instrument Co., Inc.
Ophthalmic
✕
5
devices
1-5 of 5
Filters
Cleared
Feb 05, 1988
IRAS EDS INTERFEROMETRIC STIMULATOR
K873990
·
HLX
Ophthalmic
·
127d
Cleared
Nov 24, 1987
IRAS GLARE TESTER
K873987
·
HLJ
Ophthalmic
·
56d
Cleared
Dec 12, 1986
IRAS PERIMETER
K864012
·
HPJ
Ophthalmic
·
58d
Cleared
Nov 01, 1985
LASER IRAS
K853556
·
HPJ
Ophthalmic
·
67d
Cleared
Aug 15, 1984
PORTABLE ACUIOMETER
K842567
·
HLJ
Ophthalmic
·
44d
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6
Ophthalmic
5
Radiology
1