510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
80
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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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
FDA 510(k) cleared devices by Planmeca Oy
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 26, 1999
PLANMECA INTRACAM STATION
K984013
·
EIA
Dental
·
76d
Cleared
Jun 20, 1997
PLANMECA INTRACAM
K972033
·
EIA
Dental
·
18d
Cleared
Oct 24, 1996
PROSTYLE COMPACT
K963209
·
KLC
Dental
·
69d
Cleared
Sep 10, 1996
PROSTYLE COMPACT
K961420
·
EIA
Dental
·
151d
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28
Radiology
24
Dental
4