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
17089–17112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Jun 03, 2021
Intellihab System
K210604 · IPF
Cymedica Orthopedics, Inc.
Physical Medicine · 94d
Cleared Jun 03, 2021
Breezeway II
K210627 · DYB
Oscor, Inc.
Cardiovascular · 93d
Cleared Jun 03, 2021
ASTRA Spine System
K211323 · NKB
Spinecraft, LLC
Orthopedic · 34d
Cleared Jun 03, 2021
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium...
K211401 · GEX
Gyrus Acmi, Inc.
General & Plastic Surgery · 28d
Cleared Jun 02, 2021
BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter...
K200891 · FOZ
Becton, Dickinson and Company
General Hospital · 425d
Cleared Jun 02, 2021
Surgical Face Mask
K203190 · FXX
Rfx+Care Manufactoring Co., Ltd.
General Hospital · 218d
Cleared Jun 02, 2021
NATRELLE INSPIRA Single Use Sizers for Gel Implants
K203229 · MRD
Allergan
General & Plastic Surgery · 212d
Cleared Jun 02, 2021
Disposable Medical mask
K210150 · FXX
Hubei Wanli Protective Products Co.,...
General Hospital · 132d
Cleared Jun 02, 2021
Transpara 1.7.0
K210404 · QDQ
Screenpoint Medical B.V.
Radiology · 112d
Cleared Jun 02, 2021
Disposable Surgical Face Mask
K210429 · FXX
Jiangxi Heying Pharmaceutical Co., Ltd.
General Hospital · 110d
Cleared Jun 02, 2021
SeaSpine WaveForm™ A Interbody System
K210583 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 96d
Cleared Jun 02, 2021
6MS Invisible Aligner
K210652 · NXC
Sms Opco, LLC
Dental · 90d
Cleared Jun 02, 2021
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment...
K211051 · HRS
DePuy Synthes
Orthopedic · 55d
Cleared Jun 02, 2021
Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application...
K211372 · QMY
Mahana Therapeutics, Inc.
Gastroenterology & Urology · 29d
Cleared Jun 02, 2021
ASM-301 Level 3 Surgical Mask
K211440 · FXX
American Surgical Mask Company, LLC
General Hospital · 23d
Cleared Jun 01, 2021
Well-Life Garment Electrodes (GM Series)
K200942 · GXY
Well-Life Healthcare Limited
Neurology · 419d
Cleared Jun 01, 2021
Arthrex Beveled FT Screws
K210994 · HWC
Arthrex, Inc.
Orthopedic · 60d
Cleared May 28, 2021
LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and...
K200607 · LPH
Waldemar Link GmbH & Co. KG
Orthopedic · 445d
Cleared CT May 28, 2021
ABT12 multi-purpose solution
K202932 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 241d
Cleared May 28, 2021
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension...
K203687 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 162d
Cleared May 28, 2021
INVU by Nuvo
K210025 · LQK
Nuvo- Group , Ltd.
Obstetrics & Gynecology · 144d
Cleared May 28, 2021
coraCross
K210188 · DQY
Reflow Medical
Cardiovascular · 123d
Cleared May 28, 2021
Infant Phototherapy Equipment
K210289 · LBI
Bistos Co., Ltd.
General Hospital · 115d
Cleared May 28, 2021
Irrisept Antimicrobial Wound Lavage
K210536 · FQH
Irrimax Corporation
General & Plastic Surgery · 93d