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
67297–67320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 2004
VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
K043103 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Dec 09, 2004
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
K043110 · FLL
Microlife Intellectual Property GmbH
General Hospital · 29d
Cleared Dec 09, 2004
BEST RADIOPAQUE STRAND
K043117 · KXK
Best Medical International, Inc.
Radiology · 29d
Cleared Dec 09, 2004
STARION UNIVERSAL POWER SUPPLY (UPS)
K043155 · HQO
Starion Instruments
Ophthalmic · 24d
Cleared Dec 09, 2004
PRIMUS STENT AND DELIVERY SYSTEM
K043243 · FGE
Ev3, Inc.
Gastroenterology & Urology · 16d
Cleared Dec 09, 2004
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
K043275 · IYO
Olympus Medical Systems Corporation
Radiology · 13d
Cleared Dec 08, 2004
BIOZDX HEMODYNAMIC MONITOR
K041294 · DSB
Cardiodynamics International Corp.
Cardiovascular · 208d
Cleared Dec 08, 2004
ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN,...
K042574 · KGO
Cardinalhealth
General Hospital · 77d
Cleared Dec 08, 2004
VARELISA SM ANTIBODIES, MODEL 18296
K042629 · LKP
Sweden Diagnostics (Germany) GmbH
Immunology · 72d
Cleared Dec 08, 2004
LPS UPPER EXTREMITY
K042664 · JDC
Depuy, Inc.
Orthopedic · 71d
Cleared Dec 08, 2004
TUF LINK SILICONE RELINER
K042931 · EBI
Dentatus USA , Ltd.
Dental · 47d
Cleared Dec 08, 2004
BICONTACT HIP SYSTEM WITH U-CAP
K043079 · MEH
Aesculap
Orthopedic · 30d
Cleared Dec 08, 2004
EXPRESS AND OASIS CHEST DRAIN
K043140 · CAC
Atrium Medical Corp.
Anesthesiology · 23d
Cleared Dec 07, 2004
AEQUOS
K033260 · JWH
Aap Implantate AG
Orthopedic · 425d
Cleared Dec 07, 2004
STERICHEK BLOOD LEAK REAGENT STRIPS
K042322 · FJD
Hach Company
Gastroenterology & Urology · 103d
Cleared Dec 07, 2004
RIVA SILVER
K042452 · EMA
Southern Dental Industries, Inc.
Dental · 88d
Cleared Dec 07, 2004
TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
K042723 · DAP
Biosite Incorporated
Chemistry · 67d
Cleared Dec 07, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
K042946 · LON
bioMerieux, Inc.
Microbiology · 42d
Cleared Dec 07, 2004
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
K042970 · JSM
Copan Diagnostics, Inc.
Microbiology · 40d
Cleared Dec 07, 2004
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
K043108 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 28d
Cleared Dec 07, 2004
BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
K043193 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 19d
Cleared Dec 06, 2004
OSTIM
K030052 · LYC
Heraeus Kulzer, Inc.
Dental · 700d
Cleared Dec 06, 2004
AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER
K040865 · FRG
Aesculap
General Hospital · 248d
Cleared Dec 06, 2004
NEXFLEX TOTAL HIP SYSTEM
K042252 · LPH
Alphatec/Nexmed
Orthopedic · 108d