510k
Database
Specialties
Anesthesiology
328
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1055
Chemistry
267
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793
Ear, Nose, Throat
147
Gastroenterology & Urology
617
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1303
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745
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97
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72
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1
Microbiology
364
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560
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240
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154
Orthopedic
2026
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38
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309
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1566
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129
Categories
GEX
Powered Laser Surgical Instrument
227
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Plate, Fixation, Bone
207
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System, Imaging, Pulsed Doppler,...
206
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Automated Radiological Image...
203
LLZ
System, Image Processing,...
197
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
167
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
136
NKB
Thoracolumbosacral Pedicle Screw...
133
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Proteins Intl., Inc.
Medical Device Manufacturer
·
US , Rochester Hills , MI
Proteins Intl., Inc. - FDA 510(k) Cleared Devices
54 submissions
·
54 cleared
·
Since 1992
54
Total
54
Cleared
0
Denied
FDA 510(k) Regulatory Record - Proteins Intl., Inc.
Microbiology
✕
3
devices
1-3 of 3
Filters
Cleared
May 17, 1996
CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM
K961755
·
JSN
Microbiology
·
11d
Cleared
May 17, 1996
CYTOQUANT VIRAL TRANSPORT MEDIUM
K961756
·
JSN
Microbiology
·
11d
Cleared
Jan 15, 1993
CYTOQUANT COMBINED TRANSPORT MEDIA
K924053
·
LIO
Microbiology
·
156d
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54
Pathology
51
Microbiology
3