510k
Database
Specialties
Anesthesiology
465
Cardiovascular
1405
Chemistry
334
Dental
1097
Ear, Nose, Throat
202
Gastroenterology & Urology
827
General & Plastic Surgery
1843
General Hospital
1316
Hematology
124
Immunology
86
Medical Genetics
7
Microbiology
420
Neurology
787
Obstetrics & Gynecology
351
Ophthalmic
222
Orthopedic
2450
Pathology
47
Physical Medicine
420
Radiology
2024
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
300
LLZ
System, Image Processing,...
297
GEI
Electrosurgical, Cutting &...
257
QIH
Automated Radiological Image...
254
IYN
System, Imaging, Pulsed Doppler,...
244
HRS
Plate, Fixation, Bone
242
LZA
Polymer Patient Examination Glove
231
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Lafayette Pharmacal, Inc.
Medical Device Manufacturer
·
US , Lafayette , IN
Lafayette Pharmacal, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
3 cleared
·
Since 1986
4
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lafayette Pharmacal, Inc.
Gastroenterology & Urology
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 28, 1989
MAGLINTE ENTEROCLYSIS CATHETER
K884379
·
FGD
Gastroenterology & Urology
·
133d
Cleared
Jul 08, 1988
SITZMARKS
K881609
·
FFX
Gastroenterology & Urology
·
87d
Cleared
Mar 12, 1986
ENTROKIT WITH MAGLINTE CATHETER
K860441
·
KGC
Gastroenterology & Urology
·
36d
Filters
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All
4
Gastroenterology & Urology
3
Radiology
1