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
27889–27912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2017
Easyret
K170067 · HQF
Quantel Medical
Ophthalmic · 197d
Cleared Jul 25, 2017
LightMed Dental Laser System
K170073 · GEX
Lightmed Dentaltechnology Corp.
General & Plastic Surgery · 197d
Cleared Jul 25, 2017
Spinal Manometer NRFit
K170305 · FMJ
PAJUNK GmbH Medizintechnologie
General Hospital · 175d
Cleared Jul 25, 2017
ANCHORMAN Tibial Ligament Fixation Device
K170388 · MBI
Summit Medical , Ltd.
Orthopedic · 167d
Cleared Jul 25, 2017
CARTO 3 EP Navigation System, Version 6.0 and Accessories
K170600 · DQK
Biosense Webster, Inc.
Cardiovascular · 146d
Cleared Jul 25, 2017
CT Midline
K170770 · PND
Medical Components, Inc. (dba MedComp)
General Hospital · 133d
Cleared Jul 25, 2017
FTRD System Set
K170867 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 124d
Cleared Jul 25, 2017
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
K170997 · DYB
Biosense Webster, Inc.
Cardiovascular · 113d
Cleared Jul 25, 2017
Monteris Medical NeuroBlate System
K171255 · GEX
Monteris Medical, Inc.
General & Plastic Surgery · 88d
Cleared Jul 25, 2017
LumFuse-TP
K171630 · MAX
Precifit Medical, Ltd.
Orthopedic · 53d
Cleared Jul 25, 2017
CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound...
K171645 · KGN
Strukmyer Medical
General & Plastic Surgery · 50d
Cleared Jul 25, 2017
HP PRO Positioning Device
K171734 · IYE
Orfit Industries NV
Radiology · 43d
Cleared Jul 25, 2017
TomoTherapy Treatment Delivery System with iDMS
K171837 · IYE
Accuray Incorporated
Radiology · 35d
Cleared Jul 25, 2017
Radiance V4
K171885 · MUJ
Gmv Soluciones Globales Internet S.A.U.
Radiology · 29d
Cleared Jul 25, 2017
Rubicon 14, 18 and 35 Support Catheters
K171913 · DQY
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jul 25, 2017
MagVita TMS Therapy System
K171967 · OBP
Tonica Elektronik A/S
Neurology · 25d
Cleared Jul 24, 2017
Custom Bars
K162633 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 306d
Cleared Jul 24, 2017
NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
K162858 · LZC
Careplus (M) Sdn Bhd
General Hospital · 285d
Cleared Jul 24, 2017
YELLOW 560 Fluorescence Module
K162991 · IZI
Carl Zeiss Meditec, AG
Radiology · 270d
Cleared Jul 24, 2017
Infant Transport Mattress Warmer with Disc
K163295 · IMD
Rapid Aid Corp.
Physical Medicine · 244d
Cleared Jul 24, 2017
DRACO Locking Bone Screws
K163486 · KTT
Hnm Total Recon, LLC
Orthopedic · 224d
Cleared Jul 24, 2017
JAWS(TM) Nitinol Staple System
K170923 · JDR
Paragon 28
Orthopedic · 117d
Cleared Jul 24, 2017
ARIX Diaphysis System
K171285 · HRS
Jeil Medical Corporation
Orthopedic · 84d
Cleared Jul 24, 2017
MP LeFort I Plates
K171364 · JEY
Stryker
Dental · 76d