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896
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2920
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933
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2062
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370
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1754
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3301
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3009
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208
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223
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15
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807
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1459
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701
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467
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4605
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70
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653
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4108
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314
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LLZ
System, Image Processing,...
700
GEX
Powered Laser Surgical Instrument
510
IYN
System, Imaging, Pulsed Doppler,...
501
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Polymer Patient Examination Glove
483
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Electrosurgical, Cutting &...
469
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Plate, Fixation, Bone
412
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
391
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System, Nuclear Magnetic...
345
NKB
Thoracolumbosacral Pedicle Screw...
343
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Manufacturers
US
Astra Tech, Inc.
Medical Device Manufacturer
·
US , Waltham , MA
Astra Tech, Inc. - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 1994
28
Total
28
Cleared
0
Denied
28
devices
26-28 of 28
Filters
1
2
Cleared
Mar 24, 1998
ASTRA TECH IMPLANT DENTAL SYSTEM
K974737
·
DZE
Dental
·
95d
Cleared
Mar 19, 1998
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K980698
·
DZE
Dental
·
24d
Cleared
Feb 08, 1994
ASTRA TECH IMPLANTS-DENTAL SYSTEM
K931767
·
DZE
Dental
·
306d
1
2
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28
Dental
24
Gastroenterology & Urology
4