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
62689–62712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2006
RAPIDTOX
K053359 · DKZ
American Bio Medica Corp.
Toxicology · 174d
Cleared May 25, 2006
PURE-AID PREGNANCY TEST
K053452 · LCX
Bio Focus Co., Lt.
Chemistry · 164d
Cleared May 25, 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128 · LCX
Unipath , Ltd.
Chemistry · 127d
Cleared May 25, 2006
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
K060157 · MVM
Immco Diagnostics, Inc.
Immunology · 125d
Cleared May 25, 2006
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
K060227 · MYA
Vision Biosystems, Inc.
Pathology · 115d
Cleared May 25, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT...
K060324 · LON
Becton, Dickinson & CO
Microbiology · 105d
Cleared May 25, 2006
STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
K060506 · MQP
Stryker Spine
Orthopedic · 87d
Cleared May 25, 2006
VANGUARD REMOVABLE MOLDED POLY TIBIA
K060525 · JWH
Biomet Manufacturing Corp
Orthopedic · 87d
Cleared May 25, 2006
LTV 1200 VENTILATOR
K060647 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 73d
Cleared May 25, 2006
PROCEED SURGICAL MESH
K060713 · FTL
Ethicon, Inc.
General & Plastic Surgery · 69d
Cleared May 25, 2006
40 L HIGH FLOW INSUFFLATOR F113
K060723 · HIF
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 69d
Cleared May 25, 2006
POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE...
K060726 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 69d
Cleared May 25, 2006
MEMORY STAPLE
K060746 · JDR
DePuy Orthopaedics, Inc.
Orthopedic · 66d
Cleared May 25, 2006
ACMI DUR-HL LASER SYSTEMS
K060752 · GEX
Acmi Corporation
General & Plastic Surgery · 65d
Cleared May 25, 2006
SURGICAL FACE MASK
K060776 · FXX
Hong YA Non-Woven Products Co., Ltd.
General Hospital · 64d
Cleared May 25, 2006
BREAS, MODEL HA01
K060790 · BTT
Breas Medical AB
Anesthesiology · 63d
Cleared May 25, 2006
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
K060811 · CAF
Omron Healthcare, Inc.
Anesthesiology · 62d
Cleared May 25, 2006
MODIFICATION TO REBILDA DC
K060893 · EBF
Voco GmbH
Dental · 52d
Cleared May 25, 2006
ARCHITECT BNP ASSAY, MODEL 8K28
K060964 · NBC
Fujirebio Diagnostics,Inc.
Chemistry · 48d
Cleared May 25, 2006
MODIFIED MERCI RETRIEVER, MODEL 90092
K061059 · NRY
Concentric Medical, Inc.
Neurology · 38d
Cleared May 25, 2006
TRABECULAR METAL ACETABULAR AUGMENTS
K061067 · LPH
Zimmer Trabecular
Orthopedic · 38d
Cleared May 25, 2006
3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000
K061170 · MOS
Resonance Innovations, LLC
Radiology · 28d
Cleared May 25, 2006
CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2
K061182 · JJY
Cliniqa Corporation
Chemistry · 28d
Cleared May 25, 2006
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX...
K061238 · KHS
Dade Behring, Inc.
Chemistry · 22d