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
67993–68016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 2004
MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL
K042342 · MOS
Usa Instruments, Inc.
Radiology · 25d
Cleared Sep 24, 2004
MODIFIED SPACEMAKER SYSTEM
K042412 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 17d
Cleared Sep 24, 2004
QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085
K042442 · DCK
Orion Diagnostica, OY
Chemistry · 15d
Cleared Sep 23, 2004
MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
K041127 · NLF
Sterilmed, Inc.
Anesthesiology · 146d
Cleared Sep 23, 2004
IMPLANTEO IMPLANTOLOGY MOTOR
K041279 · EKX
Anthogyr
Dental · 133d
Cleared Sep 23, 2004
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS
K041591 · JWH
Howmedica Osteonics Corp.
Orthopedic · 101d
Cleared Sep 23, 2004
MODIFICATION TO VBR SPINAL SYSTEM
K041722 · MQP
Depuy Spine, Inc.
Orthopedic · 91d
Cleared Sep 23, 2004
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
K041909 · DQO
Vascular Solutions, Inc.
Cardiovascular · 70d
Cleared Sep 23, 2004
DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
K042016 · MSD
Datascope Corp.
Gastroenterology & Urology · 58d
Cleared Sep 23, 2004
CLIPPER DIAGNOSTIC ELECTRODE CATHETER
K042105 · DRF
Bard Electrophysiology
Cardiovascular · 50d
Cleared Sep 23, 2004
D-VAPOR
K042276 · CAD
Draeger Medical, Inc.
Anesthesiology · 31d
Cleared Sep 23, 2004
STOCKERT SCP RHYTHM
K042374 · DWA
Stockert Instrumente GmbH
Cardiovascular · 22d
Cleared Sep 23, 2004
Lysus Infusion System
K042456 · QEY
Ekos Corp.
Cardiovascular · 13d
Cleared Sep 22, 2004
CLARISSA INFANT NCPAP CANNULA
K032922 · CBK
Airways Ltd., Inc.
Anesthesiology · 366d
Cleared Sep 22, 2004
MHLX7EC TRANSDUCER
K040213 · ITX
Microhelix, Inc.
Radiology · 236d
Cleared Sep 22, 2004
MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
K040915 · MWI
Invivo Research, Inc.
Cardiovascular · 167d
Cleared Sep 22, 2004
IPLAN! FLOW
K041330 · HAW
Brainlab AG
Neurology · 126d
Cleared Sep 22, 2004
AMBU DISPOSABLE ECG ELECTRODE
K041734 · DRX
Ambu, Inc.
Cardiovascular · 89d
Cleared Sep 22, 2004
CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
K041890 · OCL
Cryocor, Inc.
Cardiovascular · 72d
Cleared Sep 22, 2004
MANTRA ELECTRODE
K041902 · GXY
Mantra Intl. (Hk) , Ltd.
Neurology · 70d
Cleared Sep 22, 2004
SMARTINFUSER PAINPUMP
K042122 · MEB
Precise Medical Products
General Hospital · 47d
Cleared Sep 22, 2004
TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78...
K042426 · MEG
Taiject Medical Device Co., Ltd.
General Hospital · 14d
Cleared Sep 22, 2004
HOLTER PLUS
K042463 · DQK
Rozinn Electronics, Inc.
Cardiovascular · 9d
Cleared Sep 21, 2004
ARTELON SPACER CMC-1
K040070 · KYI
Artimplant AB
Orthopedic · 251d