510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1656
Chemistry
360
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
957
General & Plastic Surgery
2175
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2038
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126
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97
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8
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462
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958
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433
Ophthalmic
274
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2830
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52
Physical Medicine
515
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2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Engstrom Medical
Medical Device Manufacturer
·
US , Sturgis , MI
Engstrom Medical - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1995
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Engstrom Medical
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 26, 1995
DISPOSABLE FLEX TUBE
K954197
·
BZA
Anesthesiology
·
50d
Cleared
Oct 20, 1995
DISPOSABLE HME/FILTER
K954194
·
BYD
Anesthesiology
·
44d
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Anesthesiology
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