510k
Database
Specialties
Anesthesiology
325
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1053
Chemistry
267
Dental
788
Ear, Nose, Throat
147
Gastroenterology & Urology
612
General & Plastic Surgery
1298
General Hospital
740
Hematology
97
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72
Medical Genetics
1
Microbiology
363
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554
Obstetrics & Gynecology
240
Ophthalmic
152
Orthopedic
2011
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38
Physical Medicine
307
Radiology
1557
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129
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
207
IYN
System, Imaging, Pulsed Doppler,...
205
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Automated Radiological Image...
203
LLZ
System, Image Processing,...
195
GEI
Electrosurgical, Cutting &...
183
OLO
Orthopedic Stereotaxic Instrument
166
NHA
Abutment, Implant, Dental,...
152
MAX
Intervertebral Fusion Device...
136
NKB
Thoracolumbosacral Pedicle Screw...
132
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Planmeca Oy
Medical Device Manufacturer
·
FI , Helsinki
Planmeca Oy - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 1993
28
Total
28
Cleared
0
Denied
28
devices
26-28 of 28
Filters
1
2
Cleared
Dec 11, 1995
PROSTYLE INTRA
K955429
·
EHD
Radiology
·
13d
Cleared
Oct 07, 1995
PANORAMIC X-RAY UNIT (MODIFICATION)
K952763
·
EHD
Radiology
·
135d
Cleared
Dec 15, 1993
PANORAMIC X-RAY UNITS, MODIFICATION
K934063
·
EHD
Radiology
·
106d
1
2
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28
Radiology
24
Dental
4