510k
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Anesthesiology
554
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1738
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387
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258
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478
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456
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3094
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518
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2524
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Categories
LZA
Polymer Patient Examination Glove
424
LLZ
System, Image Processing,...
403
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Powered Laser Surgical Instrument
370
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Mask, Surgical
361
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Electrosurgical, Cutting &...
313
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System, Imaging, Pulsed Doppler,...
307
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Plate, Fixation, Bone
300
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Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
241
MAX
Intervertebral Fusion Device...
235
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Manufacturers
US
Plasmedics, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Plasmedics, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1982
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Plasmedics, Inc.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 25, 1985
PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY
K850263
·
BSJ
Anesthesiology
·
61d
Cleared
Sep 26, 1983
APNEA ALARM FOR ADULT-PEDIATRIC & NEON
K831601
·
BZQ
Anesthesiology
·
131d
Cleared
Sep 12, 1983
ANESTHESIA/RESPIRATORY DISCONNECT -
K831650
·
BZQ
Anesthesiology
·
112d
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6
Anesthesiology
3
General Hospital
1
General & Plastic Surgery
1
Cardiovascular
1