FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13873–13896 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2022
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike...
K212211 · DQY
Vascular Solutions, LLC
Cardiovascular · 209d
Cleared Feb 09, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K212213 · PQA
Cepheid
Microbiology · 209d
Cleared Feb 09, 2022
CloudCath Peritoneal Dialysis Drain Set Monitoring System
K212658 · FKX
Cloudcath
Gastroenterology & Urology · 170d
Cleared Feb 09, 2022
Actively Trying Personal Lubricant Unfragrance
K212705 · PEB
CC Wellness, LLC
Obstetrics & Gynecology · 167d
Cleared Feb 09, 2022
Redline
K213297 · NXC
Johns Dental Laboratories
Dental · 131d
Cleared Feb 09, 2022
Lucy Breast Pump
K213311 · HGX
Willow Innovations, Inc.
Obstetrics & Gynecology · 128d
Cleared Feb 09, 2022
Veinoflow SCD (Model: LBTK-M-I 5006)
K213313 · JOW
Dalian Labtek Science & Development...
Cardiovascular · 128d
Cleared Feb 09, 2022
PELNAC Wound Matrix
K213573 · KGN
Gunze Limited
General & Plastic Surgery · 91d
Cleared Feb 09, 2022
DeGen Navigated Instrumentation
K213918 · OLO
Degen Medical
Orthopedic · 56d
Cleared Feb 09, 2022
Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™...
K214011 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 49d
Cleared Feb 09, 2022
SDC4K Information Management System with Device and Voice Control Package
K220108 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 27d
Cleared Feb 08, 2022
PathBuilder Steerable Introducer
K211530 · DYB
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 267d
Cleared Feb 08, 2022
O'Star Nitrile Examination Gloves Powder Free
K213058 · LZA
Star Investment and Trade Joint Stock...
General Hospital · 139d
Cleared Feb 08, 2022
Rapid
K213165 · LLZ
Ischemaview, Inc.
Radiology · 133d
Cleared Feb 08, 2022
AcQCross Qx Integrated Transseptal Dilator/Needle
K220047 · DYB
Acutus Medical, Inc.
Cardiovascular · 34d
Cleared Feb 07, 2022
ELEC-LED
K201191 · EBW
Micro-Nx Co., Ltd.
Dental · 644d
Cleared Feb 07, 2022
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
K212431 · JDG
Biomet, Inc.
Orthopedic · 187d
Cleared Feb 04, 2022
Noris Medical Dental Implants System
K210356 · NHA
Noris Medical , Ltd.
Dental · 361d
Cleared Feb 04, 2022
F3D-C2 Cervical Stand-Alone System
K211417 · OVE
Corelink, LLC
Orthopedic · 273d
Cleared Feb 04, 2022
smart-sync
K212271 · LNH
Northh Medical GmbH
Radiology · 199d
Cleared Feb 04, 2022
Magnifico Open, Magnifico MSK
K212419 · LNH
Esaote, S.P.A.
Radiology · 184d
Cleared Feb 04, 2022
Micro C Medical Imaging System, M01
K212654 · IZL
Oxos Medical, Inc.
Radiology · 165d
Cleared Feb 04, 2022
Genex Bone Graft Substitute
K212721 · MQV
Biocomposites, Ltd.
Orthopedic · 161d
Cleared Feb 04, 2022
BD Vacutainer UltraTouch Push Button Blood Collection Set
K212724 · JKA
Becton, Dickinson and Company
General Hospital · 161d