510k
Database
Specialties
Anesthesiology
408
Cardiovascular
1229
Chemistry
306
Dental
926
Ear, Nose, Throat
178
Gastroenterology & Urology
725
General & Plastic Surgery
1579
General Hospital
966
Hematology
112
Immunology
79
Medical Genetics
4
Microbiology
400
Neurology
688
Obstetrics & Gynecology
296
Ophthalmic
183
Orthopedic
2225
Pathology
43
Physical Medicine
369
Radiology
1805
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
259
LLZ
System, Image Processing,...
252
QIH
Automated Radiological Image...
236
IYN
System, Imaging, Pulsed Doppler,...
223
GEI
Electrosurgical, Cutting &...
220
HRS
Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
183
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
146
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Planmeca USA, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Planmeca USA, Inc. - FDA 510(k) Cleared Devices
13 submissions
·
13 cleared
·
Since 1984
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Planmeca USA, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 23, 2011
PLANMED NUANCE EXCEL
K111361
·
MUE
Radiology
·
130d
Cleared
Mar 04, 1993
ADMARK
K923533
·
JAC
Radiology
·
231d
Cleared
Apr 18, 1991
PLANMED SOPHIE
K904953
·
IZH
Radiology
·
164d
Cleared
Nov 26, 1986
DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC
K864474
·
EHD
Radiology
·
13d
Filters
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13
Dental
8
Radiology
4
Anesthesiology
1