510k
Database
Specialties
Anesthesiology
494
Cardiovascular
1528
Chemistry
348
Dental
1205
Ear, Nose, Throat
223
Gastroenterology & Urology
885
General & Plastic Surgery
2011
General Hospital
1555
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
437
Neurology
871
Obstetrics & Gynecology
387
Ophthalmic
254
Orthopedic
2612
Pathology
49
Physical Medicine
473
Radiology
2183
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
327
LLZ
System, Image Processing,...
323
LZA
Polymer Patient Examination Glove
301
GEI
Electrosurgical, Cutting &...
279
QIH
Automated Radiological Image...
265
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
254
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
202
MAX
Intervertebral Fusion Device...
189
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Alba Health Care
Medical Device Manufacturer
·
US , Mchenry , IL
Alba Health Care - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1981
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alba Health Care
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 07, 1985
INFANT PHOTOTHERAPY MASK
K851918
·
FOK
General Hospital
·
36d
Cleared
Mar 04, 1981
PROCEDURE & RECOVERY PATIENT SUIT
K803171
·
FYB
General Hospital
·
79d
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8
General & Plastic Surgery
5
General Hospital
2
Orthopedic
1