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
24025–24048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2018
Implant Planning Software
K173965 · LLZ
Inteware Co., Ltd.
Radiology · 301d
Cleared Oct 26, 2018
PENTAX Medical Video Colonoscope EC34-i10T Series
K180285 · FDF
Pentax Medical of America, Inc.
Gastroenterology & Urology · 267d
Cleared Oct 26, 2018
Polyethylene Catheter
K180286 · DQO
Cook Incorporated
Cardiovascular · 267d
Cleared Oct 26, 2018
Cook Silicone Balloon HSG Catheter
K180291 · LKF
Cook Incorporated
Obstetrics & Gynecology · 267d
Cleared Oct 26, 2018
Margolin HSG Cannula, Goldstein Sonohysterography Catheter
K180300 · LKF
Cook Incorporated
Obstetrics & Gynecology · 266d
Cleared Oct 26, 2018
Peak.me
K180487 · BZH
Breathe Me, Ltd.
Anesthesiology · 245d
Cleared Oct 26, 2018
TSI Transseptal Introducer
K181031 · DYB
Pressure Products Medical Device...
Cardiovascular · 191d
Cleared Oct 26, 2018
Invisalign System with Mandibular Advancement Feature
K181739 · NXC
Align Technology, Inc.
Dental · 116d
Cleared Oct 26, 2018
Two-Step Implant System
K181898 · HWC
Trilliant Surgical
Orthopedic · 102d
Cleared Oct 26, 2018
Dexcom G6 Glucose Program Continuous Glucose Monitoring System
K182041 · QDK
Dexcom, Inc.
Chemistry · 88d
Cleared Oct 26, 2018
Accipiolx
K182177 · QAS
Maxq-Al , Ltd.
Radiology · 77d
Cleared Oct 26, 2018
MAGNETOM Aera
K182299 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 63d
Cleared Oct 26, 2018
Hair Laser Headband
K182501 · OAP
Pulsaderm, LLC
General & Plastic Surgery · 44d
Cleared Oct 26, 2018
A6 OTC Pain Relief TENS
K182753 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 28d
Cleared Oct 26, 2018
V2 OTC Pain Relief TENS
K182767 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 28d
Cleared Oct 25, 2018
Swaive Thermometer SWT1A
K170723 · FLL
E-Care Technology Co., Ltd.
General Hospital · 595d
Cleared Oct 25, 2018
Endocular Viewing Lenses and Silicone Ring
K173944 · HJK
Phakos
Ophthalmic · 303d
Cleared Oct 25, 2018
SpeediCath Standard
K180258 · GBM
Coloplast
Gastroenterology & Urology · 268d
Cleared Oct 25, 2018
SLENDERTONE CoreFit Abs 8, Type 734
K180688 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 224d
Cleared Oct 25, 2018
CONVIVO
K181116 · GWG
Carl Zeiss Meditec, AG
General & Plastic Surgery · 181d
Cleared Oct 25, 2018
Solitare Platinum Revascularization Device
K181186 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 175d
Cleared Oct 25, 2018
074 Zenith Flex System
K181354 · NRY
Inneuroco, Inc.
Neurology · 156d
Cleared Oct 25, 2018
Hybrid3D
K181468 · KPS
Hermes Medical Solutions AB
Radiology · 143d
Cleared Oct 25, 2018
Vivid E80, Vivid E90, Vivid E95
K181685 · IYN
GE Medical Systems Ultrasound and...
Radiology · 121d