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
25897–25920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2018
InTice™-C Porous Ti Cervical Interbody System
K173832 · ODP
X-Spine Systems, Inc.
Orthopedic · 150d
Cleared May 17, 2018
MindMotion(TM) GO
K173931 · LXJ
Mindmaze SA
Physical Medicine · 142d
Cleared CT May 17, 2018
FlowTriever Retrieval/Aspiration System
K180466 · QEW
Inari Medical, Inc.
Cardiovascular · 85d
Cleared May 17, 2018
EnsoETM
K180742 · PLA
Advanced Cooling Therapy, Inc. D/B/A...
Cardiovascular · 56d
Cleared May 17, 2018
Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon...
K181023 · LOX
Meril Life Sciences Private Limited
Cardiovascular · 30d
Cleared May 17, 2018
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
K181042 · DXK
Boston Scientific Corporation
Cardiovascular · 28d
Cleared May 17, 2018
Navigated INFINITY Instruments
K181111 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared May 16, 2018
Varian Cervical Sleeves
K172675 · JAQ
Varian Medical Systems, Inc.
Radiology · 253d
Cleared May 16, 2018
Additive Orthopaedics Patient Specific 3D Printed Bone Segments
K180239 · HRS
Additive Orthopaedics, LLC
Orthopedic · 107d
Cleared May 16, 2018
HARRIER-SA™ Lumbar Interbody System
K180519 · OVD
Choicespine, LP
Orthopedic · 78d
Cleared May 16, 2018
IS3
K180527 · EKX
Hiossen, Inc.
Dental · 77d
Cleared May 16, 2018
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
K180819 · LPL
Menicon Co, Ltd.
Ophthalmic · 48d
Cleared May 16, 2018
Low Dose CT Lung Cancer Screening Option
K180901 · JAK
Hitachi Healthcare Americas
Radiology · 40d
Cleared May 16, 2018
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
K180906 · JWH
Conformis, Inc.
Orthopedic · 40d
Cleared May 15, 2018
Metacem
K171449 · EMA
Meta Biomed Co., Ltd.
Dental · 363d
Cleared May 15, 2018
Astroid Planning App
K173940 · MUJ
.Decimal, LLC
Radiology · 140d
Cleared May 15, 2018
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and...
K180412 · QEW
Penumbra, Inc.
Cardiovascular · 89d
Cleared May 15, 2018
reVive Light Therapy LED Ultrasonic Wrinkle System
K180445 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 84d
Cleared May 15, 2018
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K180476 · LZC
Comfort Rubber Gloves Industries Sdn....
General Hospital · 82d
Cleared May 15, 2018
CustomizedBone Service
K180513 · GXN
Fin-Ceramica Faenza S.P.A.
Neurology · 77d
Cleared May 15, 2018
Guided Growth Plate System Plus
K180624 · OBT
Orthofix Srl
Orthopedic · 67d
Cleared May 15, 2018
Reliance Lumber IBF System
K180687 · MAX
Reliance Medical Systems
Orthopedic · 61d
Cleared May 15, 2018
5D Viewer
K180883 · LLZ
Samsung Medison Co., Ltd.
Radiology · 41d
Cleared May 15, 2018
XableCath Support Catheter Product Family
K180986 · DQY
Xablecath, Inc.
Cardiovascular · 29d