510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1681
Chemistry
368
Dental
1339
Ear, Nose, Throat
249
Gastroenterology & Urology
977
General & Plastic Surgery
2196
General Hospital
2048
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2943
Pathology
52
Physical Medicine
515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
279
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Laerdal California, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Laerdal California, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1983
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Laerdal California, Inc.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
May 18, 1994
STATVAC PORTABLE SUCTION UNIT
K941578
·
BTA
General & Plastic Surgery
·
48d
Cleared
Nov 03, 1986
E-VAC(TM)
K862875
·
BTA
General & Plastic Surgery
·
96d
Filters
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5
Anesthesiology
2
General & Plastic Surgery
2
Physical Medicine
1