510k
Database
Specialties
Anesthesiology
202
Cardiovascular
731
Chemistry
187
Dental
459
Ear, Nose, Throat
87
Gastroenterology & Urology
387
General & Plastic Surgery
759
General Hospital
468
Hematology
77
Immunology
62
Medical Genetics
1
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274
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293
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113
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76
Orthopedic
1468
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26
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150
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1078
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
164
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
129
LLZ
System, Image Processing,...
123
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
104
GEI
Electrosurgical, Cutting &...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Hd Lifesciences, LLC
Medical Device Manufacturer
·
US , Stoneham , MA
Hd Lifesciences, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Hd Lifesciences, LLC
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 28, 2020
Hive™ Stand-alone Anterior Lumbar Interbody System
K200541
·
OVD
Orthopedic
·
56d
Cleared
Jun 27, 2018
HD LifeSciences Cervical IBFD System
K180364
·
ODP
Orthopedic
·
135d
Cleared
Jul 13, 2017
HD Lumbar Interbody System
K170676
·
MAX
Orthopedic
·
129d
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Orthopedic
3