510k
Database
Specialties
Anesthesiology
473
Cardiovascular
1429
Chemistry
335
Dental
1127
Ear, Nose, Throat
210
Gastroenterology & Urology
838
General & Plastic Surgery
1885
General Hospital
1421
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
425
Neurology
811
Obstetrics & Gynecology
360
Ophthalmic
235
Orthopedic
2470
Pathology
49
Physical Medicine
434
Radiology
2056
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
304
LZA
Polymer Patient Examination Glove
273
GEI
Electrosurgical, Cutting &...
260
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
244
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
171
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Sgarlato Laboratories, Inc.
Medical Device Manufacturer
·
US , San Jose , CA
Sgarlato Laboratories, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1989
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sgarlato Laboratories, Inc.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 21, 1998
THREADED FIXATION PIN
K982931
·
JDW
Orthopedic
·
62d
Cleared
Oct 23, 1992
LUNDEEN SUBTALAR PEG IMPLANT
K922292
·
MJW
Orthopedic
·
161d
Cleared
May 29, 1991
SGARLATO FLEXIBLE HINGE TOE IMPLANT
K905795
·
KWH
Orthopedic
·
153d
Cleared
May 18, 1989
SGARLATO LESSER TOE IMPLANT
K884739
·
KWH
Orthopedic
·
185d
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8
Orthopedic
4
General Hospital
2
Neurology
1
Physical Medicine
1