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
27121–27144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2017
Riptide Aspiration System
K172448 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 129d
Cleared Dec 21, 2017
OMNI ARC Anteverted Neck Hip Stem
K172467 · LZO
Omnilife Science
Orthopedic · 128d
Cleared Dec 21, 2017
PREMIUM ONE Implant Systems
K172560 · DZE
Sweden & Martina S.P.A.
Dental · 118d
Cleared Dec 21, 2017
NuVasive Navigation Instruments
K172623 · OLO
Nu Vasive, Incorporated
Orthopedic · 111d
Cleared Dec 21, 2017
SafeSept Needle Free Transseptal Guidewire
K172893 · DRC
Pressure Products Medical Device...
Cardiovascular · 90d
Cleared Dec 21, 2017
MMPC-4127F1
K172922 · PZZ
Barco N.V.
Pathology · 87d
Cleared Dec 21, 2017
SeaSpine Vu cPOD, Zuma-C, Complete Cervical
K172926 · ODP
SeaSpine Orthopedics Corporation
Orthopedic · 87d
Cleared Dec 21, 2017
easyEndoTM Linear Cutting Stapler and Loading Units for Single Use,...
K172960 · GDW
Ezisurg Medical Co., Ltd.
General & Plastic Surgery · 86d
Cleared Dec 21, 2017
Life Spine Foot and Ankle Plating System
K172973 · HRS
Life Spine, Inc.
Orthopedic · 86d
Cleared Dec 21, 2017
Solana GBS Assay
K173250 · NJR
Quidel Corporation
Microbiology · 72d
Cleared Dec 21, 2017
Elite HV Radial
K173287 · DYB
Galt Medical Corp.
Cardiovascular · 66d
Cleared Dec 21, 2017
OMNI Surgical System
K173332 · MRH
Sight Sciences, Inc.
Ophthalmic · 59d
Cleared Dec 21, 2017
Anterior Cervical Plate System
K173375 · KWQ
Evolution Spine, LLC
Orthopedic · 55d
Cleared Dec 20, 2017
Pobling MIITY 2
K163550 · NFO
Habalan Med & Beauty Co.,Ltd
Neurology · 366d
Cleared Dec 20, 2017
Well-Root ST
K170950 · KIF
Vericom Co., Ltd.
Dental · 264d
Cleared Dec 20, 2017
Apex Tibial Nailing System
K170972 · HSB
Orthoxel
Orthopedic · 261d
Cleared Dec 20, 2017
Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus...
K171275 · DYB
Cook Incorporated
Cardiovascular · 233d
Cleared Dec 20, 2017
Sentrant Introducer Sheath with Hydrophilic Coating
K171866 · DYB
Medtronic Vascular, Inc.
Cardiovascular · 181d
Cleared Dec 20, 2017
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx...
K172565 · PWJ
Boston Scientific Corporation
Gastroenterology & Urology · 117d
Cleared Dec 20, 2017
Breakaway Screw System
K172886 · HRS
Paragon 28
Orthopedic · 90d
Cleared Dec 20, 2017
Electric Breast Pump
K172989 · HGX
Joytech Healthcare Co. , Ltd.
Obstetrics & Gynecology · 84d
Cleared Dec 20, 2017
COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS,...
K173115 · ODP
Globus Medical, Inc.
Orthopedic · 82d
Cleared Dec 20, 2017
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125 · MQP
Medtronic Sofamor Danek
Orthopedic · 82d
Cleared Dec 20, 2017
ProLift® Expandable System
K173182 · MAX
Life Spine, Inc.
Orthopedic · 82d