FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
19537–19560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 2020
AA temp temporary restoration 3D printing photoreactive resin
K191590 · EBG
Enlighten Materials Co., Ltd.
Dental · 326d
Cleared May 05, 2020
uMR 780
K193176 · LNH
Shanghai United Imaging Healthcare...
Radiology · 169d
Cleared May 05, 2020
AVIEW LCS
K193220 · LLZ
Coreline Soft Co., Ltd.
Radiology · 166d
Cleared May 05, 2020
InMode System with vTone Applicator
K200293 · KPI
Inmode , Ltd.
Gastroenterology & Urology · 90d
Cleared May 05, 2020
Ziostation2
K200315 · LLZ
Ziosoft, Inc.
Radiology · 88d
Cleared May 05, 2020
ZeeroMED View
K200546 · LLZ
O3 Enterprise Srl
Radiology · 63d
Cleared May 05, 2020
Balteum™ Lumbar Plate System
K200846 · KWQ
Huvexel Co. , Ltd.
Orthopedic · 35d
Cleared May 05, 2020
Healix Compression Screw System
K200914 · HWC
Nvision Biomedical Technologies, Inc.
Orthopedic · 29d
Cleared May 05, 2020
Syntec Non-Sterile Steinmann Pins System
K200933 · JDW
Syntec Scientific Corporation
Orthopedic · 28d
Cleared May 05, 2020
Lascod Impression Materials
K201184 · ELW
Lascod Spa
Dental · 4d
Cleared May 04, 2020
LIVIA
K183110 · NUH
Lifecare , Ltd.
Neurology · 543d
Cleared May 04, 2020
Revitive Medic Plus, Revitive Advanced 2
K192887 · NGX
Actegy , Ltd.
Physical Medicine · 207d
Cleared May 04, 2020
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
K193185 · OKO
Benq Materials Corporation
General & Plastic Surgery · 168d
Cleared May 04, 2020
Hamilton-G5
K193228 · CBK
Hamilton Medical AG
Anesthesiology · 164d
Cleared May 04, 2020
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
K193516 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 137d
Cleared May 04, 2020
Ultravision Visual Field Clearing System
K200035 · PQM
Alesi Surgical, Ltd.
General Hospital · 117d
Cleared May 04, 2020
Headless Compression Screw System
K200259 · HWC
Osteocentric Extremities, LLC
Orthopedic · 91d
Cleared May 04, 2020
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical...
K200871 · QEZ
Control Medical Technology
Cardiovascular · 33d
Cleared May 02, 2020
RIST Radial Access Catheter
K200417 · QJP
Rist Neurovascular, Inc.
Neurology · 72d
Cleared May 02, 2020
BOSS Balloon Guide Catheter
K200910 · QJP
Marblehead Medical
Neurology · 26d
Cleared May 01, 2020
FUJIFILM EP-6000 Video Processor
K192286 · FET
Fujifilm Corporation
Gastroenterology & Urology · 253d
Cleared May 01, 2020
PDT-FACE
K192295 · OLP
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 252d
Cleared May 01, 2020
Image Guidance System for Radiotherapy
K192405 · IYE
Jiangsu Rayer Medical Technology Co.,...
Radiology · 241d
Cleared May 01, 2020
Kitazato ET Catheters
K192540 · MQF
Kitazato Corporation
Obstetrics & Gynecology · 228d