510k
Database
Specialties
Anesthesiology
325
Cardiovascular
1044
Chemistry
264
Dental
782
Ear, Nose, Throat
147
Gastroenterology & Urology
607
General & Plastic Surgery
1280
General Hospital
732
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
363
Neurology
552
Obstetrics & Gynecology
239
Ophthalmic
148
Orthopedic
1983
Pathology
38
Physical Medicine
307
Radiology
1546
Toxicology
128
Categories
GEX
Powered Laser Surgical Instrument
226
IYN
System, Imaging, Pulsed Doppler,...
205
HRS
Plate, Fixation, Bone
204
QIH
Automated Radiological Image...
202
LLZ
System, Image Processing,...
191
GEI
Electrosurgical, Cutting &...
179
OLO
Orthopedic Stereotaxic Instrument
166
NHA
Abutment, Implant, Dental,...
151
MAX
Intervertebral Fusion Device...
136
NKB
Thoracolumbosacral Pedicle Screw...
130
Browse all 339 categories →
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About
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Ambu A/S
Medical Device Manufacturer
·
US , Glen Burnie , MD
Ambu A/S - FDA 510(k) Cleared Devices
38 submissions
·
38 cleared
·
Since 2005
Official Website
38
Total
38
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ambu A/S
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 30, 2026
Ambu® Virobac II® Exhalation Filter
K251583
·
CAH
General Hospital
·
342d
Filters
Filter by Specialty
All
38
Ear, Nose, Throat
13
Gastroenterology & Urology
11
Anesthesiology
7
Neurology
3
Cardiovascular
3
General Hospital
1