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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
59665–59688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 2007
KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
K062096 · LCX
Koreamedico Co. , Ltd.
Chemistry · 287d
Cleared May 07, 2007
FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE
K063363 · LJS
Flexicath , Ltd.
General Hospital · 181d
Cleared May 07, 2007
MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE...
K063545 · DJG
Alfa Scientific Designs, Inc.
Toxicology · 164d
Cleared May 07, 2007
LENSTEC LC INJECTION SYSTEM
K063802 · MSS
Lenstec, Inc.
Ophthalmic · 136d
Cleared May 07, 2007
NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY...
K070068 · CGL
Nova Biomedical Corp.
Chemistry · 119d
Cleared May 07, 2007
SURFLO WINGED INFUSION SET
K070362 · FPA
Terumo Europe N.V.
General Hospital · 89d
Cleared May 07, 2007
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 80d
Cleared May 07, 2007
MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
K070475 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 76d
Cleared May 07, 2007
TRACKRECORD DATA MANAGEMENT SOFTWARE
K070593 · NBW
Home Diagnostics, Inc.
Chemistry · 66d
Cleared May 07, 2007
TOP-RANK ADHESIVE ELECTRODE
K070612 · GXY
Top-Rank Health Care Equipment Co., Ltd.
Neurology · 63d
Cleared May 07, 2007
AERONEB PROFESSIONAL NEBULIZER SYSTEM
K070642 · CAF
Aerogen (Ireland), Ltd.
Anesthesiology · 60d
Cleared May 07, 2007
NASOPORE EAR
K070715 · NHB
Polyganics B.V.,
Ear, Nose, Throat · 54d
Cleared May 07, 2007
CHAD THERAPEUTICS BONSAI MODEL 800
K070740 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 52d
Cleared May 07, 2007
GROWTH CONTROL PLATING SYSTEM
K070823 · HRS
Biomet Trauma
Orthopedic · 42d
Cleared May 05, 2007
NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
K070326 · MNR
Widemed, Ltd.
Anesthesiology · 89d
Cleared May 04, 2007
DBEST HCG PANEL TEST KIT
K061257 · JHI
Ameritek USA, Inc.
Chemistry · 365d
Cleared May 04, 2007
SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405)
K062784 · FLL
Sejoy Electronics & Instruments Co.,...
General Hospital · 228d
Cleared May 04, 2007
LIFESENSE, MODEL LS1-9R
K063752 · DQA
Nonin Medical, Inc.
Anesthesiology · 136d
Cleared May 04, 2007
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
K070054 · LCX
Church & Dwight Co., Inc.
Chemistry · 120d
Cleared May 04, 2007
CARTO XP EP NAVIGATION SYSTEM, VERSION 9
K070240 · DQK
Biosense Webster, Inc.
Cardiovascular · 99d
Cleared May 04, 2007
ACQUASEAL BENZ
K070289 · LBH
Acquamed Technologies, Inc.
Dental · 94d
Cleared May 04, 2007
UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES
K070331 · KPI
Laborie Medical Technologies
Gastroenterology & Urology · 88d
Cleared May 04, 2007
TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM
K070368 · NKB
Stryker Corp.
Orthopedic · 85d
Cleared May 04, 2007
LAGWIRE SYSTEM
K070393 · HWC
Fxdevices
Orthopedic · 84d