510k
Database
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Anesthesiology
471
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1416
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334
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1117
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208
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835
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1872
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1374
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125
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87
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8
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424
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807
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354
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233
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2467
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48
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429
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2041
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145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
301
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Electrosurgical, Cutting &...
258
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Automated Radiological Image...
255
LZA
Polymer Patient Examination Glove
252
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Sulzermedica
Medical Device Manufacturer
·
US , Austin , TX
Sulzermedica - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1999
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sulzermedica
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 24, 2000
MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
K002324
·
JDI
Orthopedic
·
24d
Cleared
Dec 01, 1999
APR METASUL ACETABULAR INSERT
K993569
·
KWA
Orthopedic
·
41d
Filters
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5
Cardiovascular
3
Orthopedic
2