510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1701
Chemistry
374
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2214
General Hospital
2063
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
439
Ophthalmic
282
Orthopedic
2988
Pathology
52
Physical Medicine
515
Radiology
2471
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
414
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
301
HRS
Plate, Fixation, Bone
284
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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L H M Ent., Inc.
Medical Device Manufacturer
·
US , Palm Harbor , FL
L H M Ent., Inc. - FDA 510(k) Cleared Devices
6 submissions
·
4 cleared
·
Since 1988
6
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - L H M Ent., Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
May 18, 1990
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
K901078
·
BTO
Anesthesiology
·
72d
Cleared
May 18, 1990
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
K901079
·
BTO
Anesthesiology
·
72d
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6
General Hospital
2
Anesthesiology
2
General & Plastic Surgery
1
Gastroenterology & Urology
1