Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
40297–40320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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 CT 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
Cleared Sep 09, 2013
POWER FREE VINYL EXAMINATION GLOVES
K122102 · LYZ
Wang Tong Xinghua Co., Ltd.
General Hospital · 420d
Cleared Sep 09, 2013
FRESENIUS LIBERTY CYCLER
K123630 · FKX
Fresenius Medical Care North America,...
Gastroenterology & Urology · 290d
Cleared Sep 09, 2013
RESPIRE PINK SERIES - HERBST
K131138 · LRK
Respire Medical
Dental · 139d
Cleared Sep 09, 2013
EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
K132073 · DQK
St Jude Medical
Cardiovascular · 68d
Cleared Sep 09, 2013
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
K132216 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 54d
Cleared Sep 09, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K132465 · PSZ
Princeton BioMeditech Corp.
Microbiology · 33d
Cleared Sep 06, 2013
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K121033 · NOT
Ventana Medical Systems, Inc.
Pathology · 519d
Cleared Sep 06, 2013
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
K121844 · LYY
Worldmed Manufacturing Sdn. Bhd.
General Hospital · 438d
Cleared Sep 06, 2013
RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
K122235 · JOH
Teleflexmedical, Inc.
Anesthesiology · 407d
Cleared Sep 06, 2013
PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
K130010 · NYI
Nanostring Technologies
Pathology · 246d