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
18409–18432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2020
Philips Avent Single/Double electric breast pump Advanced
K201381 · HGX
Philips Consumer Lifestyle -...
Obstetrics & Gynecology · 128d
Cleared Oct 01, 2020
HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
K201446 · DQK
Edwards Lifesiences, LLC
Cardiovascular · 122d
Cleared Oct 01, 2020
Nutricare Clear-ISOSAF Nasogastric Feeding Tube
K202357 · PIF
Three Circles Consulting Limited
Gastroenterology & Urology · 43d
Cleared Sep 30, 2020
THINQ
K192051 · LLZ
Corticometrics, LLC
Radiology · 427d
Cleared Sep 30, 2020
Tua Face Fitness / Tua Trend Face
K192077 · NFO
Vupiesse S.R.L
Neurology · 425d
Cleared Sep 30, 2020
IDS-iSYS Ostase BAP
K200475 · CIN
Immunodiagnostic Systems , Ltd.
Chemistry · 217d
Cleared Sep 30, 2020
Clear Guide SCENERGY
K201188 · JAK
Clear Guide Medical
Radiology · 152d
Cleared Sep 30, 2020
e-Ortho Shoulder Software
K201928 · LLZ
FH Industrie
Radiology · 82d
Cleared Sep 30, 2020
EverLift Submucosal Lifting Agent
K202376 · PLL
Gi Supply, Inc.
Gastroenterology & Urology · 41d
Cleared Sep 30, 2020
Allura Vaginal Stent
K202542 · KXP
Pmt Corporation
Obstetrics & Gynecology · 28d
Cleared Sep 30, 2020
DigitalDiagnost C90
K202564 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 26d
Cleared Sep 30, 2020
Wiygul Catheter
K202566 · EZD
Big Blue Biotech, Inc.
Gastroenterology & Urology · 26d
Cleared Sep 29, 2020
PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50...
K191738 · DPS
Philips Medical Systems
Cardiovascular · 459d
Cleared Sep 29, 2020
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal...
K193131 · BSP
Becton, Dickinson and Company
Anesthesiology · 322d
Cleared Sep 29, 2020
Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants
K193401 · DZE
Altatec GmbH
Dental · 298d
Cleared Sep 29, 2020
Dual Cure Resin Cement
K201790 · EMA
Rizhao Huge Biomaterials Company, Ltd.
Dental · 91d
Cleared Sep 29, 2020
Cadwell Apollo System
K201819 · GWQ
Cadwell Industries, Inc.
Neurology · 90d
Cleared Sep 29, 2020
Cefaly Dual
K201895 · PCC
Cefaly Technology
Neurology · 83d
Cleared Sep 29, 2020
LVivo Seamless
K202546 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 27d
Cleared Sep 28, 2020
da Vinci SP Surgical System
K192717 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 367d
Cleared Sep 28, 2020
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
K193299 · LON
bioMerieux, Inc.
Microbiology · 306d
Cleared Sep 28, 2020
Enteral Feeding Syringes with ENfit connector (Model: 10 ml
K200557 · PNR
Jiangsu Shenli Medical Production...
Gastroenterology & Urology · 209d
Cleared Sep 28, 2020
Electrosurgical Generator
K201221 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 145d
Cleared Sep 28, 2020
RIST Radial Access Catheter
K201682 · QJP
Rist Neurovascular, Inc.
Neurology · 98d