FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
29137–29160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 2017
A-dec NLZ Electric Motor System
K163131 · EBW
Nakanishi, Inc.
Dental · 184d
Cleared May 11, 2017
Longitudinal Brain Imaging (LoBI) application
K163250 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 174d
Cleared CT May 11, 2017
Fully Automatic Electronic Blood Pressure Monitor
K163276 · DXN
Andon Health Co, Ltd.
Cardiovascular · 171d
Cleared May 11, 2017
GORE SYNECOR Preperitoneal Biomaterial
K163576 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 143d
Cleared May 11, 2017
Lung Vision
K163622 · LLZ
Bodyvision Medical , Ltd.
Radiology · 140d
Cleared May 11, 2017
TREFOIL System
K170135 · DZE
Nobel Biocare AB
Dental · 114d
Cleared May 11, 2017
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
K170205 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 108d
Cleared May 11, 2017
Arthrex Compression Screws
K170382 · HWC
Arthrex, Inc.
Orthopedic · 93d
Cleared May 11, 2017
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR...
K170413 · LIP
Bio-Rad Laboratories
Microbiology · 90d
Cleared May 11, 2017
SurgiCase Viewer
K170419 · LLZ
Materialise NV
Radiology · 87d
Cleared May 11, 2017
Solana C. difficile Assay
K170491 · OZN
Quidel Corporation
Microbiology · 83d
Cleared May 11, 2017
Mako Total Knee Application
K170581 · OLO
Mako Surgical Corp.
Orthopedic · 72d
Cleared May 11, 2017
Mako Partial Knee Application
K170584 · OLO
Mako Surgical Corp.
Orthopedic · 72d
Cleared May 11, 2017
Connector System
K170647 · NKG
Orthofix, Inc.
Orthopedic · 69d
Cleared May 11, 2017
ANTHEM CR Total Knee System
K170648 · JWH
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared May 11, 2017
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the...
K170679 · NKB
Medtronic Sofamor Danek
Orthopedic · 66d
Cleared May 11, 2017
Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator
K170990 · GEI
Spiration, Inc.
General & Plastic Surgery · 38d
Cleared May 11, 2017
GMR40
K171085 · MQB
Neurologica Corporation, A Subsidiary OF
Radiology · 29d
Cleared May 10, 2017
MALUC™ Total Hip Arthroplasty System
K162125 · JDI
Surgtech, Inc.
Orthopedic · 282d
Cleared May 10, 2017
ABCcolla Collagen Matrix
K162348 · KGN
Acro Biomedical Co., Ltd.
General & Plastic Surgery · 261d
Cleared May 10, 2017
Lubricity
K163476 · LFD
You First Services, Incorporated
Dental · 149d
Cleared May 10, 2017
I.B.S. osteosynthesis screws
K170594 · HWC
In2bones Sas
Orthopedic · 71d
Cleared May 10, 2017
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
K170650 · KTT
Orthofix Srl
Orthopedic · 68d
Cleared May 10, 2017
ALP IFCC Gen.2
K171080 · CJE
Roche Diagnostics Operations (Rdo)
Chemistry · 29d