510k
Database
Specialties
Anesthesiology
492
Cardiovascular
1510
Chemistry
344
Dental
1192
Ear, Nose, Throat
220
Gastroenterology & Urology
871
General & Plastic Surgery
1976
General Hospital
1529
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
436
Neurology
863
Obstetrics & Gynecology
379
Ophthalmic
253
Orthopedic
2593
Pathology
49
Physical Medicine
464
Radiology
2162
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
321
LLZ
System, Image Processing,...
319
LZA
Polymer Patient Examination Glove
296
GEI
Electrosurgical, Cutting &...
276
QIH
Automated Radiological Image...
263
IYN
System, Imaging, Pulsed Doppler,...
258
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
184
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Holter-Hausner Intl.
Medical Device Manufacturer
·
US , Mchenry , IL
Holter-Hausner Intl. - FDA 510(k) Cleared Devices
42 submissions
·
38 cleared
·
Since 1978
42
Total
38
Cleared
0
Denied
FDA 510(k) Regulatory Record - Holter-Hausner Intl.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 16, 1985
H-H HUNTER PASSIVE TENDON IMPLANT
K853436
·
HXR
General & Plastic Surgery
·
62d
Filters
Filter by Specialty
All
42
Neurology
28
Orthopedic
8
Gastroenterology & Urology
3
General & Plastic Surgery
1
Anesthesiology
1
General Hospital
1