510k
Database
Specialties
Anesthesiology
522
Cardiovascular
1610
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2131
General Hospital
1978
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
940
Obstetrics & Gynecology
426
Ophthalmic
271
Orthopedic
2697
Pathology
52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
367
GEX
Powered Laser Surgical Instrument
350
FXX
Mask, Surgical
347
GEI
Electrosurgical, Cutting &...
294
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Actuated Medical, Inc.
Medical Device Manufacturer
·
US , Bellefonte , PA
Actuated Medical, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2012
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Actuated Medical, Inc.
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 31, 2022
IO Needle Safety Sheath
K220890
·
FMI
General Hospital
·
217d
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10
Gastroenterology & Urology
9
General Hospital
1