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

Filters: Cleared only ×
175,820 results
44785–44808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2012
INFRARED EAR THEROMETER
K111703 · FLL
Fudakang Industrial Co., Ltd.
General Hospital · 286d
Cleared Mar 29, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE...
K112538 · CHH
Alfa Wassermann Diagnostic...
Chemistry · 210d
Cleared Mar 29, 2012
IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS
K112702 · LGZ
Imperial Surgical , Ltd.
General Hospital · 195d
Cleared Mar 29, 2012
LOCKING COMPRESSION PLATE SYSTEM
K112798 · HRS
Shanghai Microport Orthopedics Co., Ltd.
Orthopedic · 184d
Cleared Mar 29, 2012
ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION...
K112863 · KNT
Acta Medical, LLC
Gastroenterology & Urology · 181d
Cleared Mar 29, 2012
TIGER SPINE SYSTEM
K113058 · NKB
Corelink, LLC
Orthopedic · 167d
Cleared Mar 29, 2012
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING...
K113233 · KGO
Shen Wei (Usa), Inc.
General Hospital · 148d
Cleared Mar 29, 2012
VPAP ST-A
K113288 · MNS
Resmed, Ltd.
Anesthesiology · 143d
Cleared Mar 29, 2012
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K113327 · KTT
Stryker Corp.
Orthopedic · 140d
Cleared Mar 29, 2012
INFANT ARRAY
K113365 · MOS
Advanced Imaging Research Dba Sree...
Radiology · 135d
Cleared Mar 29, 2012
ACDS
K120005 · KPO
Isopure, Corp.
Gastroenterology & Urology · 86d
Cleared Mar 29, 2012
MCOMPASS ANORECTAL MANOMETRY SYSTEM
K120088 · KLA
Medspira, LLC
Gastroenterology & Urology · 78d
Cleared Mar 29, 2012
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206 · LZG
Medtronic Minimed
General Hospital · 66d
Cleared Mar 29, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
K120568 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 31d
Cleared Mar 29, 2012
ACCOLADE II HIP STEM
K120578 · JDI
Howmedica Osteonics
Orthopedic · 31d
Cleared Mar 29, 2012
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
K120616 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 29d
Cleared Mar 29, 2012
TOSHIBA 1.5T QD HEAD COIL
K120627 · MOS
Quality Electrodynamics
Radiology · 28d
Cleared Mar 29, 2012
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
K120738 · LIT
Ostial Corporation
Cardiovascular · 17d
Cleared Mar 29, 2012
IMAGER II ANGIOGRAPHIC CATHETERS
K120893 · DQO
Boston Scientific Corp
Cardiovascular · 6d
Cleared Mar 28, 2012
SMARTPILOT VIEW MODEL MK04500
K103035 · BSZ
Draeger Medical GmbH
Anesthesiology · 532d
Cleared CT Mar 28, 2012
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR...
K110587 · LFR
Bayer Healthcare, LLC
Chemistry · 393d
Cleared Mar 28, 2012
ONE PERSONAL LUBRICANT (SILICONE)
K110690 · NUC
One
Obstetrics & Gynecology · 383d
Cleared CT Mar 28, 2012
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
K110894 · LFR
Bayer Healthcare
Chemistry · 364d
Cleared Mar 28, 2012
RESIGLASS PASTE
K112307 · EMA
Shofu Dental Corporation
Dental · 230d