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
27001–27024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2018
Besmed Peak Flow Meter
K172804 · BZH
Besmed Health Business Corp
Anesthesiology · 115d
Cleared Jan 11, 2018
Diazyme EZ Vitamin D Assay
K172992 · MRG
Diazyme Laboratories
Chemistry · 106d
Cleared Jan 11, 2018
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4
K173090 · IYN
Toshibamedical Systems Corporation
Radiology · 104d
Cleared Jan 10, 2018
VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
K171421 · NKB
Silony Medical GmbH
Orthopedic · 240d
Cleared Jan 10, 2018
Amplatz Support Wire Guide with Apex Curve
K171445 · DQX
Cook Incorporated
Cardiovascular · 239d
Cleared Jan 10, 2018
Electrodes with snap / Electrodes with pigtail
K171722 · GXY
Shenzhen Konmed Technology Co., Ltd.
Neurology · 212d
Cleared Jan 10, 2018
Digital Blood Pressure Monitor-Wrist Style
K171833 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 205d
Cleared Jan 10, 2018
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans...
K172051 · MQF
Cook Incorporated
Obstetrics & Gynecology · 188d
Cleared Jan 10, 2018
Smith & Nephew Patient Matched Cutting Blocks
K172336 · JWH
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Jan 10, 2018
Instalief
K172358 · LKX
Privi Medical Pte, Ltd.
Gastroenterology & Urology · 160d
Cleared Jan 10, 2018
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal...
K172929 · LJE
Boston Scientific Corporation
Gastroenterology & Urology · 107d
Cleared Jan 10, 2018
Epicardia Anywhere
K173170 · DSI
Medicomp, Inc.
Cardiovascular · 103d
Cleared Jan 10, 2018
Swiss LithoClast Trilogy
K173234 · FEO
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 97d
Cleared Jan 10, 2018
ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
K173563 · DXC
Tz Medical, Inc.
Cardiovascular · 54d
Cleared Jan 10, 2018
Tempus Pro Patient Monitor
K173768 · MHX
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 30d
Cleared Jan 09, 2018
Ultra/Phonic Scanning Gel
K163026 · MUI
Pharmaceutical Innovations, Inc.
Radiology · 435d
Cleared Jan 09, 2018
Ultra/Phonic Free Conductivity Gel
K163027 · MUI
Pharmaceutical Innovations, Inc.
Radiology · 435d
Cleared Jan 09, 2018
ULab Systems Treatment Planning Software
K171295 · PNN
Ulab Systems, Inc.
Dental · 252d
Cleared Jan 09, 2018
Theradome LH80 PRO
K171775 · OAP
Theradome, Inc.
General & Plastic Surgery · 209d
Cleared Jan 09, 2018
Guided Growth Plate System Plus
K172183 · OBT
Orthofix Srl
Orthopedic · 174d
Cleared Jan 09, 2018
Modified Alma Lasers Soprano XL™ Family ofMulti-Application &...
K172193 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 172d
Cleared Jan 09, 2018
MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™
K172212 · ODP
Ctl Medical Corporation
Orthopedic · 169d
Cleared Jan 09, 2018
reVive Perioral
K172662 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 126d
Cleared Jan 09, 2018
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
K173021 · IYN
Supersonic Imagine
Radiology · 103d