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
39697–39720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
K132578 · KRD
Boston Scientific Corp
Cardiovascular · 28d
Cleared Sep 12, 2013
SURGICAL GOWN (EO STERILIZED)
K112796 · FYA
Cobes Industries Co., Ltd.
General Hospital · 717d
Cleared Sep 12, 2013
JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
K124037 · FMF
Jung Rim Medical Industrial Co., Ltd.
General Hospital · 258d
Cleared Sep 12, 2013
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
K130417 · KLW
Audifon-USA, Inc.
Ear, Nose, Throat · 205d
Cleared Sep 12, 2013
UNIVERSAL PASTE STAINS AND GLAZE
K130604 · EIH
Prismatik Dentalcraft, Inc.
Dental · 189d
Cleared Sep 12, 2013
VIVORTE BVF
K130703 · MBP
Vivorte, Inc.
Orthopedic · 181d
Cleared Sep 12, 2013
AUTOMATIC BLOOD PRESSURE MONITOR
K130925 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 162d
Cleared Sep 12, 2013
IPROPHY MOBILE
K131578 · EKX
Nakanishi, Inc.
Dental · 104d
Cleared Sep 12, 2013
EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
K131802 · OSH
Depuy Spine, A Johnson & Johnson Company
Orthopedic · 85d
Cleared Sep 12, 2013
MULTISTIM
K132137 · IPF
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 63d
Cleared Sep 12, 2013
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
K132198 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 58d
Cleared Sep 12, 2013
QXLINK
K132302 · LLZ
Vieworks Co., Ltd.
Radiology · 50d
Cleared Sep 12, 2013
ACCULIF TL AND PL CAGE
K132505 · MAX
Coalign Innovations, Inc.
Orthopedic · 31d
Cleared Sep 11, 2013
SHOFU BLOCK HC
K130841 · EBF
Shofu Dental Corporation
Dental · 169d
Cleared Sep 11, 2013
PULSE OXIMETER
K131021 · DQA
Nonin Medical, Inc.
Anesthesiology · 152d
Cleared Sep 11, 2013
IHEALTH FINGERTIP PULSE OXIMETER
K131111 · DQA
Andon Health Co, Ltd.
Anesthesiology · 145d
Cleared Sep 11, 2013
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT...
K131208 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 135d
Cleared Sep 11, 2013
KITAZATO IUI CATHETER
K131491 · MQF
Kitazato Medical Co., Ltd.
Obstetrics & Gynecology · 111d
Cleared Sep 11, 2013
XTAG CYP2C19 KIT V3
K131565 · NTI
Luminex Molecular Diagnostics, Inc.
Toxicology · 104d
Cleared Sep 10, 2013
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
K123567 · LCX
Church & Dwight Co., Inc.
Chemistry · 294d
Cleared Sep 10, 2013
CCS-200 SPIROMETER
K123896 · BZG
Benson Medical Instruments Co.
Anesthesiology · 266d
Cleared Sep 10, 2013
APEX UNIVERSAL ADHESIVE
K131043 · KLE
Apex Dental Materials, Inc.
Dental · 148d
Cleared Sep 10, 2013
TIGER SPINE SYSTEM
K131250 · NKB
Corelink, LLC
Orthopedic · 131d
Cleared Sep 10, 2013
RETROGRADE FEMORAL NAIL
K132005 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 71d