510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1654
Chemistry
360
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
957
General & Plastic Surgery
2175
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
958
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Pikdare Spa
Medical Device Manufacturer
·
IT , Casnate Con Bernate
Pikdare Spa - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pikdare Spa
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 20, 2023
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
K203792
·
FMI
General Hospital
·
753d
Cleared
Dec 02, 2022
DropSafeTM SicuraTM
K223353
·
FMI
General Hospital
·
30d
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2
General Hospital
2