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
20137–20160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT 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
Cleared May 01, 2020
GUS831 Compressor Nebulizer
K192633 · CAF
Globalcare Medical Technology Co., Ltd.
Anesthesiology · 221d
Cleared May 01, 2020
Optimized Positioning System (OPS) Insight
K192656 · LLZ
Corin USA
Radiology · 219d
Cleared May 01, 2020
Stone Retrieval Balloon
K200173 · GCA
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 99d
Cleared May 01, 2020
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal)...
K200279 · DHB
Phadia AB
Immunology · 87d
Cleared May 01, 2020
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS...
K200453 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 67d
Cleared May 01, 2020
PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
K200571 · NKG
Spineart
Orthopedic · 58d
Cleared May 01, 2020
O-Genesis Graft Delivery System
K200606 · FMF
Orthofix, Inc.
General & Plastic Surgery · 53d
Cleared May 01, 2020
Carnation Ambulatory Monitor
K200870 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared May 01, 2020
Azurion R2.1
K200917 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 25d
Cleared May 01, 2020
Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless...
K201004 · MQB
Iray Technology Taicang , Ltd.
Radiology · 15d