510k
Database
Specialties
Anesthesiology
516
Cardiovascular
1597
Chemistry
356
Dental
1292
Ear, Nose, Throat
234
Gastroenterology & Urology
924
General & Plastic Surgery
2123
General Hospital
1927
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
935
Obstetrics & Gynecology
425
Ophthalmic
269
Orthopedic
2686
Pathology
52
Physical Medicine
508
Radiology
2310
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
395
LLZ
System, Image Processing,...
364
GEX
Powered Laser Surgical Instrument
348
FXX
Mask, Surgical
315
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
272
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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Spm Medicare Pvt. , Ltd.
Medical Device Manufacturer
·
IN , Gautam Budh Nagar
Spm Medicare Pvt. , Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spm Medicare Pvt. , Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 06, 2024
Insulin Syringe
K233794
·
FMF
General Hospital
·
99d
Cleared
Nov 09, 2023
Flush Syringe (Prefilled 0.9% normal saline solution)
K231724
·
NGT
General Hospital
·
149d
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2
General Hospital
2