510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
Dental
1341
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2201
General Hospital
2052
Hematology
126
Immunology
99
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8
Microbiology
472
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969
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436
Ophthalmic
279
Orthopedic
2961
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52
Physical Medicine
515
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2457
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
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Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
231
MAX
Intervertebral Fusion Device...
221
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DreaMed Diabetes, Ltd.
Medical Device Manufacturer
·
IL , Petah Tikva, Pob 3271
DreaMed Diabetes, Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 2018
5
Total
4
Cleared
1
Denied
FDA 510(k) Regulatory Record - DreaMed Diabetes, Ltd.
Chemistry
✕
5
devices
1-5 of 5
Filters
Cleared
Oct 03, 2023
endo.digital Platform
K232722
·
QCC
Chemistry
·
28d
Cleared
Sep 28, 2021
Advisor Pro Platform
K210561
·
QCC
Chemistry
·
215d
Cleared
Aug 28, 2020
DreaMed Advisor Pro
K201476
·
QCC
Chemistry
·
86d
Cleared
Jul 18, 2019
DreaMed Advisor Pro
K191370
·
QCC
Chemistry
·
57d
Not Cleared
Jun 12, 2018
DreaMed Advisor Pro
DEN170043
·
QCC
Chemistry
·
299d
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5
Chemistry
5