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
54025–54048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2009
FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS...
K090509 · DQY
Abbott Vascular-Vascular Solutions
Cardiovascular · 22d
Cleared Mar 20, 2009
DIAMONDBACK 360 DBX
K090521 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 22d
Cleared Mar 19, 2009
AFFIRM CO2 AND AFFIRM CO2 HP
K081424 · GEX
Cynosure, Inc.
General & Plastic Surgery · 303d
Cleared Mar 19, 2009
ACTICARE IC AND TSE
K081835 · GZJ
Bioinduction Limited
Neurology · 265d
Cleared Mar 19, 2009
REMESENSE
K082594 · LBH
Remedent NV
Dental · 192d
Cleared Mar 19, 2009
APNEALINK PLUS, MODEL: 22328
K083575 · MNR
Resmed Germany, Inc.
Anesthesiology · 106d
Cleared Mar 19, 2009
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
K083675 · NIE
C.R. Bard, Inc.
Gastroenterology & Urology · 98d
Cleared Mar 19, 2009
FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL...
K083697 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 94d
Cleared Mar 19, 2009
BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70
K083801 · DJZ
Khn Solutions, LLC
Toxicology · 87d
Cleared Mar 19, 2009
EOI SPINAL SYSTEM
K083825 · NKB
Expanding Orthopedics, Inc.
Orthopedic · 87d
Cleared Mar 19, 2009
PICC (CT RATED AND NON-RATED)
K083873 · LJS
Pfm Medical, Inc.
General Hospital · 80d
Cleared Mar 19, 2009
FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)
K083892 · DQA
Cas Medical Systems, Inc.
Anesthesiology · 80d
Cleared Mar 19, 2009
HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
K090108 · ITI
Hoveround Corp.
Physical Medicine · 63d
Cleared Mar 19, 2009
TAC-TITE (TM)
K090128 · GAT
Core Essence Orthopaedics, Inc.
General & Plastic Surgery · 57d
Cleared Mar 19, 2009
DEMASQ IMAGING SPFTWARE DEVICE
K090481 · LLZ
Demasq Limited
Radiology · 23d
Cleared Mar 19, 2009
GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV
K090524 · INI
Pride Mobility Products Corp.
Physical Medicine · 21d
Cleared Mar 19, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090537 · LYZ
Tangshan Jiteng Plastic Products Co.,...
General Hospital · 20d
Cleared Mar 18, 2009
TOKUYAMA TISSUECARE
K081554 · EBI
Tokuyama Dental Corporation
Dental · 288d
Cleared Mar 18, 2009
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
K081615 · DHX
Olympus America, Inc.
Immunology · 282d
Cleared Mar 18, 2009
INTELECT SWD 100, MODEL 1600
K083433 · IMJ
Chattanooga Group
Physical Medicine · 118d
Cleared Mar 18, 2009
C-REACTIVE PROTEIN (LATEX)
K083444 · DCN
Roche Diagnostics Corp.
Immunology · 117d
Cleared Mar 18, 2009
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
K083490 · HTY
Biopro, Inc.
Orthopedic · 113d
Cleared Mar 18, 2009
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
K083688 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 96d
Cleared Mar 18, 2009
SECURIAN TISSUE REINFORCEMENT MATRIX
K083823 · FTM
Xylos Corporation
General & Plastic Surgery · 86d