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
45241–45264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2012
IDS-ISYS INTACT PTH
K103325 · CEW
Immunodiagnostic Systems , Ltd.
Chemistry · 448d
Cleared Feb 03, 2012
BRIGHT EMBRACE MODEL SBL60
K110550 · LBI
Physician Engineered Products, Inc.
General Hospital · 343d
Cleared Feb 03, 2012
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
K111684 · HIL
Playtex Manufacturing, Inc.
Obstetrics & Gynecology · 233d
Cleared Feb 03, 2012
CONTOUR HEALER
K112099 · NHA
Contour Healer, LLC
Dental · 196d
Cleared Feb 03, 2012
PIEZOTOME SOLO
K112188 · DZI
Satelec - Acteon, Inc.
Dental · 189d
Cleared Feb 03, 2012
S-MINI IMPLANT SYSTEM
K112540 · DZE
Neobiotech Co., Ltd.
Dental · 155d
Cleared Feb 03, 2012
TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS
K112953 · IYN
Teratech Corp.
Radiology · 122d
Cleared Feb 03, 2012
CONSERVE THIN SHELL
K113322 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Feb 03, 2012
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS
K113334 · NJM
Opal Orthodontics by Ultradent...
Dental · 81d
Cleared Feb 03, 2012
CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL...
K113359 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 81d
Cleared Feb 03, 2012
CORAL SPINAL SYSTEM
K120047 · NKB
Theken Spine, LLC
Orthopedic · 28d
Cleared Feb 03, 2012
CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)
K120068 · JWH
Conformis, Inc.
Orthopedic · 25d
Cleared Feb 03, 2012
REST ASSURED GENERATION III DENTAL PROTECTOR
K120103 · OBR
Ranir, LLC
Dental · 22d
Cleared Feb 03, 2012
MANTARAY CATHETER
K120129 · DQY
Bridgepoint Medical
Cardiovascular · 17d
Cleared Feb 02, 2012
RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT
K110051 · DYB
Great Batch Medical
Cardiovascular · 391d
Cleared Feb 02, 2012
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
K112976 · LZA
Hartalega Snd. Bhd.
General Hospital · 119d
Cleared Feb 02, 2012
CMAP PRO
K113074 · IKN
Medical Technologies, Inc.
Neurology · 108d
Cleared Feb 02, 2012
MINI-MEDIC
K113165 · MWI
Athena Gtx
Cardiovascular · 99d
Cleared Feb 02, 2012
APC FLASH-FREE ADHESIVE
K113197 · DYH
3M Unitek Corporation
Dental · 94d
Cleared Feb 02, 2012
HERO GRAFT
K120006 · DSY
Hemosphere, Inc.
Cardiovascular · 30d
Cleared Feb 02, 2012
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
K120017 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Feb 01, 2012
QUICKSCREEN COCAINE 150 SCREENING TEST
K103295 · DIO
Phamatech, Inc.
Toxicology · 450d
Cleared Feb 01, 2012
ONE PERSONAL LUBRICANT (WATER BASED)
K110691 · NUC
One
Obstetrics & Gynecology · 327d
Cleared Feb 01, 2012
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
K110899 · LYR
Gold Standard Diagnostics
Microbiology · 308d