510k
Database
Specialties
Anesthesiology
540
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1660
Chemistry
362
Dental
1323
Ear, Nose, Throat
244
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957
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2179
General Hospital
2039
Hematology
126
Immunology
97
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8
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464
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960
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433
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274
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2846
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52
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515
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2417
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Implant Direct Sybron Manufacturing, LLC
Medical Device Manufacturer
·
US , Calabasas , CA
Implant Direct Sybron Manufacturing, LLC - FDA 510(k) Cleared Devices
17 submissions
·
17 cleared
·
Since 2013
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Implant Direct Sybron Manufacturing, LLC
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 16, 2023
Guided Surgery Kit
K231087
·
DZI
General Hospital
·
121d
Cleared
Jan 28, 2021
Standard Sterilizable Tray
K202524
·
KCT
General Hospital
·
149d
Cleared
Aug 06, 2020
Mini Sterilizable Tray
K200858
·
KCT
General Hospital
·
127d
Cleared
Apr 15, 2015
InterActive Complete Surgical Tray
K142519
·
KCT
General Hospital
·
219d
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17
Dental
13
General Hospital
4