510k
Database
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Anesthesiology
557
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1744
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388
Dental
1413
Ear, Nose, Throat
258
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1010
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2266
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2114
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127
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105
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8
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478
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999
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462
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292
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3125
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52
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522
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2535
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156
Categories
LZA
Polymer Patient Examination Glove
424
LLZ
System, Image Processing,...
408
GEX
Powered Laser Surgical Instrument
372
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Mask, Surgical
361
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Electrosurgical, Cutting &...
320
IYN
System, Imaging, Pulsed Doppler,...
307
HRS
Plate, Fixation, Bone
302
QIH
Automated Radiological Image...
277
MAX
Intervertebral Fusion Device...
242
OLO
Orthopedic Stereotaxic Instrument
241
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Manufacturers
US
Imm Enterprises , Ltd.
Medical Device Manufacturer
·
US , Walker , MI
Imm Enterprises , Ltd. - FDA 510(k) Cleared Devices
52 submissions
·
52 cleared
·
Since 1983
52
Total
52
Cleared
0
Denied
52
devices
51-52 of 52
Filters
1
2
3
Cleared
Dec 27, 1983
OP-CON SURGICAL INSTRUMENTS #4
K834174
·
HCZ
Obstetrics & Gynecology
·
36d
Cleared
Dec 27, 1983
H.R. JAKOBI SURG. INSTRUMENTS #4 30/31
K834177
·
HGE
Obstetrics & Gynecology
·
36d
1
2
3
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All
52
General & Plastic Surgery
25
Gastroenterology & Urology
5
Obstetrics & Gynecology
4
Ear, Nose, Throat
4
Neurology
3
Anesthesiology
3
Dental
2
Ophthalmic
2
Hematology
1
General Hospital
1