510k
Database
Specialties
Anesthesiology
328
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1055
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267
Dental
793
Ear, Nose, Throat
147
Gastroenterology & Urology
617
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1303
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745
Hematology
97
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72
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1
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364
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560
Obstetrics & Gynecology
240
Ophthalmic
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
HRS
Plate, Fixation, Bone
207
IYN
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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Remel Co.
Medical Device Manufacturer
·
US , Mchenry , IL
Remel Co. - FDA 510(k) Cleared Devices
137 submissions
·
137 cleared
·
Since 1979
137
Total
137
Cleared
0
Denied
FDA 510(k) Regulatory Record - Remel Co.
Hematology
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 16, 1991
BACTIDROP(TM) LACTOPHENOL ANILINE BLUE
K913005
·
JIO
Hematology
·
70d
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137
Microbiology
124
Pathology
12
Hematology
1