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
44329–44352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 2012
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
K121143 · DIF
Bio-Rad Laboratories
Chemistry · 32d
Cleared May 18, 2012
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF...
K121207 · LFR
Eps Bio Technology Corp.
Chemistry · 28d
Cleared May 18, 2012
BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3...
K121237 · JJX
Cliniqa Corporation
Chemistry · 24d
Cleared May 17, 2012
RESTORELLE POLYPROPYLENE Y MESH
K112322 · OTO
Coloplast A/S
Obstetrics & Gynecology · 279d
Cleared May 17, 2012
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN...
K113253 · JJE
Alfa Wassermann Diagnostic...
Chemistry · 197d
Cleared May 17, 2012
MRI SYTEMS
K113281 · LNH
Shenzhen Anke High-Tech Co., Ltd.
Radiology · 192d
Cleared May 17, 2012
EVOLUTION COLONIC STENT SYSTEM
K113510 · MQR
Cook Ireland, Ltd.
Gastroenterology & Urology · 171d
Cleared May 17, 2012
LIQUID BANDAGE
K120059 · KMF
Chesson Laboratory Associates, Inc.
General & Plastic Surgery · 129d
Cleared May 17, 2012
PRESTO BREAST BIOPSY DEVICE
K120440 · KNW
Sontina Medical, LLC
Gastroenterology & Urology · 94d
Cleared May 17, 2012
TISSUE OF ORIGIN TEST KIT FFPE
K120489 · OIW
Pathwork Diagnostics, Inc.
Pathology · 90d
Cleared May 17, 2012
MINI CANNULATED HEADED AND HEADLESS SCREW SET
K120493 · HWC
Instratek, Inc.
Orthopedic · 90d
Cleared May 17, 2012
LONG LIFE PADTM
K120516 · GXY
Omron Healthcare, Inc.
Neurology · 86d
Cleared May 17, 2012
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE...
K120729 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 69d
Cleared May 17, 2012
HAYMAX
K120894 · NUP
Haymax Limited
Ear, Nose, Throat · 55d
Cleared May 17, 2012
HEARTCHECK ECG PEN WITH GEMS HOME
K121009 · DPS
Cardiocomm Solutions, Inc.
Cardiovascular · 44d
Cleared May 17, 2012
ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM
K121138 · IYN
Siemens Medical Solution
Radiology · 34d
Cleared May 17, 2012
XPRESS MULTI-SINUS DILATION TOOL
K121174 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 30d
Cleared May 17, 2012
ARCHITECT B12
K121314 · CDD
Abbott Laboratories
Chemistry · 15d
Cleared May 17, 2012
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS
K121339 · DKZ
Chemtron Biotech, Inc.
Toxicology · 14d
Cleared May 16, 2012
FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER
K103658 · CAZ
Teleflex, Inc.
Anesthesiology · 518d
Cleared May 16, 2012
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K112127 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 296d
Cleared May 16, 2012
VARAYA AR , VARAYA SPORT
K112494 · ILY
Varaya Photoceuticals, LLC
Physical Medicine · 261d
Cleared May 16, 2012
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
K112921 · DSI
Medicalgorithmics S.A.
Cardiovascular · 226d
Cleared May 16, 2012
CLEARPATH LOWER GI
K113050 · FDF
Easyglide , Ltd.
Gastroenterology & Urology · 216d