510k
Database
Specialties
Anesthesiology
433
Cardiovascular
1312
Chemistry
327
Dental
1010
Ear, Nose, Throat
191
Gastroenterology & Urology
782
General & Plastic Surgery
1708
General Hospital
1113
Hematology
117
Immunology
83
Medical Genetics
7
Microbiology
413
Neurology
735
Obstetrics & Gynecology
323
Ophthalmic
199
Orthopedic
2374
Pathology
44
Physical Medicine
393
Radiology
1906
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
QIH
Automated Radiological Image...
247
GEI
Electrosurgical, Cutting &...
242
IYN
System, Imaging, Pulsed Doppler,...
233
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
172
MAX
Intervertebral Fusion Device...
164
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Isotis Orthobiologics, Inc.
Medical Device Manufacturer
·
NL , Bilthoven
Isotis Orthobiologics, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2004
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Isotis Orthobiologics, Inc.
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 16, 2004
ASPIREX - BONE MARROW ASPIRATE KIT
K041991
·
FMF
General Hospital
·
55d
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10
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2
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