510k
Database
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Anesthesiology
520
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1603
Chemistry
356
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1297
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234
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927
General & Plastic Surgery
2127
General Hospital
1966
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126
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91
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8
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449
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938
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425
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271
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2692
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52
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512
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2318
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155
Categories
LZA
Polymer Patient Examination Glove
401
LLZ
System, Image Processing,...
366
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Powered Laser Surgical Instrument
349
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Mask, Surgical
341
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Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
205
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Optmed, Inc.
Medical Device Manufacturer
·
US , New York , NY
Optmed, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2015
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Optmed, Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 19, 2025
BondEase 2 Topical Skin Adhesive
K243990
·
MPN
General & Plastic Surgery
·
267d
Cleared
Sep 27, 2024
TearRepair Liquid Skin Protectant
K241916
·
KMF
General & Plastic Surgery
·
88d
Cleared
Dec 22, 2015
BONDEASE TOPICAL SKIN ADHESIVE
K141157
·
MPN
General & Plastic Surgery
·
596d
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3
General & Plastic Surgery
3