510k
Database
Specialties
Anesthesiology
4802
Cardiovascular
11696
Chemistry
10237
Dental
7461
Ear, Nose, Throat
2287
Gastroenterology & Urology
6117
General & Plastic Surgery
10184
General Hospital
8449
Hematology
2320
Immunology
2895
Medical Genetics
18
Microbiology
5464
Neurology
3513
Obstetrics & Gynecology
2277
Ophthalmic
1865
Orthopedic
13944
Pathology
786
Physical Medicine
2010
Radiology
9501
Toxicology
2402
Categories
GEX
Powered Laser Surgical Instrument
1742
GEI
Electrosurgical, Cutting &...
1393
LLZ
System, Image Processing,...
1269
HRS
Plate, Fixation, Bone
1053
IYN
System, Imaging, Pulsed Doppler,...
935
DZE
Implant, Endosseous, Root-form
882
ESD
Hearing Aid, Air-conduction,...
882
LNH
System, Nuclear Magnetic...
876
GCJ
Laparoscope, General & Plastic...
858
JWH
Prosthesis, Knee,...
847
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
P/L Biomedical
Medical Device Manufacturer
·
US , Fort Myers , FL
P/L Biomedical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1997
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - P/L Biomedical
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 25, 2012
CLICKFINE PEN NEEDLE
K122969
·
FMI
General Hospital
·
29d
Cleared
Oct 25, 2012
CLICKFINE PEN NEEDLE
K122971
·
FMI
General Hospital
·
29d
Cleared
Aug 26, 1997
MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
K972135
·
FPA
General Hospital
·
81d
Filters
Filter by Specialty
All
3
General Hospital
3