510k
Database
Specialties
Anesthesiology
493
Cardiovascular
1524
Chemistry
348
Dental
1198
Ear, Nose, Throat
222
Gastroenterology & Urology
880
General & Plastic Surgery
2001
General Hospital
1544
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
437
Neurology
870
Obstetrics & Gynecology
386
Ophthalmic
254
Orthopedic
2604
Pathology
49
Physical Medicine
468
Radiology
2177
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
325
LLZ
System, Image Processing,...
322
LZA
Polymer Patient Examination Glove
297
GEI
Electrosurgical, Cutting &...
279
QIH
Automated Radiological Image...
264
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
253
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
186
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Plastafil, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Plastafil, Inc. - FDA 510(k) Cleared Devices
13 submissions
·
13 cleared
·
Since 1984
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Plastafil, Inc.
General & Plastic Surgery
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 27, 1984
STROVER HOOK
K841617
·
HCF
General & Plastic Surgery
·
130d
Cleared
Aug 27, 1984
THREADING TUBE
K841618
·
FZX
General & Plastic Surgery
·
130d
Cleared
Aug 27, 1984
HOOK
K841625
·
GAD
General & Plastic Surgery
·
130d
Cleared
Jul 11, 1984
DRILL GUIDE
K841619
·
FZX
General & Plastic Surgery
·
83d
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13
Orthopedic
9
General & Plastic Surgery
4