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
40345–40368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2013
LIAISON 25 TOTAL-D
K132492 · MRG
DiaSorin, Inc.
Chemistry · 27d
Cleared Sep 04, 2013
INTEGRA INTERSPINOUS PROCESS SYSTEM
K121924 · PEK
Seaspine, Inc.
Orthopedic · 429d
Cleared Sep 04, 2013
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
K131044 · DQD
Diacoustic Medical Devices (Pty) , Ltd.
Cardiovascular · 142d
Cleared Sep 04, 2013
BIOSPACE
K131064 · DXN
Biospace Corporation Limited
Cardiovascular · 141d
Cleared Sep 04, 2013
THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
K131148 · DYB
Access Scientific, LLC
Cardiovascular · 134d
Cleared Sep 04, 2013
POLARIS SPINAL SYSTEM
K131615 · OSH
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 93d
Cleared Sep 04, 2013
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
K131980 · NKB
Zimmer Spine, Inc.
Orthopedic · 68d
Cleared Sep 04, 2013
ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
K132045 · KPQ
Ge Hungary Kft
Radiology · 64d
Cleared Sep 04, 2013
5MP GRAYSCALE LCD DISPLAY
K132610 · LLZ
Shenzhen Beacon Display Technology...
Radiology · 15d
Cleared Sep 03, 2013
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS...
K123907 · KRR
Biomet Manufacturing Corp
Orthopedic · 258d
Cleared Sep 03, 2013
RESURFX 1565NM LASER MODULE
K130028 · ONG
Lumenis, Ltd.
General & Plastic Surgery · 243d
Cleared Sep 03, 2013
ARDIS INTERBODY SYSTEM
K131242 · MAX
Zimmer Spine, Inc.
Orthopedic · 125d
Cleared Sep 03, 2013
VARILIFT-L INTERBODY FUSION DEVICE
K131296 · MAX
Wenzel Spine, Inc.
Orthopedic · 120d
Cleared Sep 03, 2013
INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE
K131540 · MAX
Vertebral Technologies, Inc.
Orthopedic · 97d
Cleared Sep 03, 2013
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
K132366 · KWQ
Accel Spine
Orthopedic · 35d
Cleared Sep 03, 2013
U-MOTION II PS+ CUP
K132455 · LZO
United Orthopedic Corp.
Orthopedic · 28d
Cleared Aug 30, 2013
HORIZON XVU (FFR)
K123792 · DQX
Mennen Medical , Ltd.
Cardiovascular · 263d
Cleared Aug 30, 2013
ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS
K124044 · NUC
Seven Oaks Ranch, Inc.
Obstetrics & Gynecology · 242d
Cleared Aug 30, 2013
PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0
K130165 · FXN
Advanced Planimetric Services, LLC
General & Plastic Surgery · 219d
Cleared Aug 30, 2013
SIRIUS FEMORAL STEM
K130610 · JDI
Biomet, Inc.
Orthopedic · 176d
Cleared Aug 30, 2013
LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
K130792 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 161d
Cleared Aug 30, 2013
EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS
K130931 · LPL
Jiangsu Horien Contact Lens Co., Ltd.
Ophthalmic · 148d
Cleared Aug 30, 2013
INTEGRA LICOX PTO2 MONITOR
K131184 · GWM
Integra Lifesciences Corp.
Neurology · 127d
Cleared Aug 30, 2013
SWIP
K131241 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 121d