510k
Database
Specialties
Anesthesiology
433
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1310
Chemistry
327
Dental
1009
Ear, Nose, Throat
190
Gastroenterology & Urology
782
General & Plastic Surgery
1705
General Hospital
1109
Hematology
117
Immunology
83
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7
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412
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734
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321
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199
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2372
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44
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393
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1903
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141
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
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Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
241
HRS
Plate, Fixation, Bone
232
IYN
System, Imaging, Pulsed Doppler,...
232
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
171
MAX
Intervertebral Fusion Device...
163
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Stryker Leibinger
Medical Device Manufacturer
·
US , Kalamazoo , MI
Stryker Leibinger - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 1999
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stryker Leibinger
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 16, 2005
STRYKER CUSTOM TI IMPLANT
K052871
·
GXN
Neurology
·
66d
Cleared
Jun 02, 2003
STRYKER NAVIGATION SYSTEM-KNEE MODULE
K022579
·
HAW
Neurology
·
301d
Cleared
Dec 03, 2001
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY...
K012380
·
HAW
Neurology
·
130d
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12
General & Plastic Surgery
3
Neurology
3
Radiology
2
Orthopedic
2
Dental
2