510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1338
Ear, Nose, Throat
249
Gastroenterology & Urology
975
General & Plastic Surgery
2196
General Hospital
2048
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
434
Ophthalmic
279
Orthopedic
2940
Pathology
52
Physical Medicine
515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
278
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Neuwave Medical, Inc.
Medical Device Manufacturer
·
US , Madision , WI
Neuwave Medical, Inc. - FDA 510(k) Cleared Devices
15 submissions
·
15 cleared
·
Since 2010
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Neuwave Medical, Inc.
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Apr 04, 2024
ABLATE-IQ
K232227
·
JAK
Radiology
·
252d
Cleared
Oct 03, 2019
Ablation Confirmation
K192427
·
JAK
Radiology
·
28d
Cleared
May 09, 2017
Ablation Confirmation
K171022
·
JAK
Radiology
·
34d
Cleared
Jun 29, 2016
Ablation Confirmation
K161285
·
JAK
Radiology
·
51d
Cleared
Jul 09, 2015
Ablation Confirmation
K150313
·
LLZ
Radiology
·
150d
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15
General & Plastic Surgery
10
Radiology
5