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
6913–6936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2024
Disposable Hemostatic Clips
K232969 · PKL
Ningbo Xinwell Medical Technology...
Gastroenterology & Urology · 260d
Cleared Jun 07, 2024
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
K232963 · NGZ
bioMerieux, Inc.
Microbiology · 260d
Cleared Jun 07, 2024
Uro-G HD Flexible Cystoscope
K232837 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 267d
Cleared Jun 07, 2024
Electrocardiograph, model: ECG301
K232816 · DPS
Shenzhen LE Medical Technology Co., Ltd.
Cardiovascular · 268d
Cleared Jun 07, 2024
HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft...
K232806 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 269d
Cleared Jun 07, 2024
FibriCheck
K232804 · QME
Qompium NV
Cardiovascular · 269d
Cleared Jun 07, 2024
Steriking® Pouch for Robotic Instruments
K232625 · FRG
Wipak OY
General Hospital · 283d
Cleared Jun 07, 2024
Impala
K232035 · DPS
AliveCor, Inc.
Cardiovascular · 336d
Cleared Jun 07, 2024
Corvair
K231010 · MHX
AliveCor, Inc.
Cardiovascular · 427d
Cleared Jun 06, 2024
WaveSense Jazz Blood Glucose Monitoring System
K241304 · NBW
Agamatrix
Chemistry · 28d
Cleared Jun 06, 2024
CORTRAK* 2 Enteral Access System (20-0950)
K240965 · KNT
Avanos Medical, Inc.
Gastroenterology & Urology · 58d
Cleared Jun 06, 2024
Spinal System
K240963 · NKB
Teslake, Inc.
Orthopedic · 58d
Cleared Jun 06, 2024
Invictus Robotic Navigation Instruments
K240951 · OLO
Alphatec Spine
Orthopedic · 59d
Cleared Jun 06, 2024
TracStar LDP Large Distal Platform
K240948 · QJP
Imperative Care, Inc.
Neurology · 59d
Cleared Jun 06, 2024
Spine Guidance Software (version 5.0)
K240662 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 90d
Cleared Jun 06, 2024
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH)
K240657 · GEI
Livsmed, Inc.
General & Plastic Surgery · 90d
Cleared Jun 06, 2024
Conical Platform Dental Implants System
K240202 · DZE
Noris Medical , Ltd.
Dental · 133d
Cleared Jun 06, 2024
Swan-Ganz catheter
K233824 · DYG
Edwards Lifesciences, LLC
Cardiovascular · 188d
Cleared Jun 06, 2024
Wellead® Latex Foley Catheter
K233094 · MJC
Well Lead Medical (Hainan) Co., Ltd.
Gastroenterology & Urology · 254d
Cleared Jun 06, 2024
Grande Medical Masks, Model SF-600
K232968 · FXX
Golden Grande Corp.
General Hospital · 259d
Cleared Jun 06, 2024
Wearable Breast Pump,Model S18
K232774 · HGX
Ningbo Dearevery Electronic...
Obstetrics & Gynecology · 269d
Cleared Jun 05, 2024
Baby Gorilla/Gorilla Plating System
K241262 · HRS
Paragon 28, Inc.
Orthopedic · 30d
Cleared Jun 05, 2024
Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
K240648 · FLL
Radiant Innovation, Inc.
General Hospital · 90d
Cleared Jun 05, 2024
Ti-Base & Master Fix
K240603 · NHA
Arum Dentistry Co., Ltd.
Dental · 93d