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
67129–67152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2004
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
K043202 · CGS
Olympus America, Inc.
Chemistry · 35d
Cleared Dec 23, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
K043237 · LON
bioMerieux, Inc.
Microbiology · 31d
Cleared Dec 23, 2004
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
K043241 · GBM
Astra Tech, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 23, 2004
DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
K043276 · MHX
Datex-Ohmeda
Cardiovascular · 27d
Cleared Dec 23, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
K043318 · CGN
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Dec 23, 2004
INFINIA LIGHTSPEED
K043381 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 14d
Cleared Dec 22, 2004
NEOSCI MEDICAL ENDOLUMINAL BRUSH
K030400 · LJS
Neosci Medical, Inc.
General Hospital · 685d
Cleared Dec 22, 2004
12-LEAD GLOVE
K033559 · DRX
Ineedmd
Cardiovascular · 406d
Cleared Dec 22, 2004
GENCHEM ISE ELECTROLYTE REFERENCE
K040971 · JGS
Genchem, Inc.
Chemistry · 252d
Cleared Dec 22, 2004
GYNECARE PROLENE FASTENER SYSTEM
K042603 · PBQ
Ethicon, Inc.
Obstetrics & Gynecology · 89d
Cleared Dec 22, 2004
EAR THERMOMETER, MODEL WL-320X
K042631 · FLL
Innovatech, Inc.
General Hospital · 86d
Cleared Dec 22, 2004
ARCHITECT CA 15-3 ASSAY
K042732 · MOI
Fujirebio Diagnostics,Inc.
Immunology · 82d
Cleared Dec 22, 2004
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
K042760 · GGN
Pentapharm , Ltd.
Hematology · 78d
Cleared Dec 22, 2004
PEFAKIT APC-R FACTOR V LEIDEN
K042762 · GGW
Pentapharm , Ltd.
Hematology · 78d
Cleared Dec 22, 2004
TCM ENDO V, MODEL 1534
K042822 · EKX
NOUVAG AG
Dental · 71d
Cleared Dec 22, 2004
NEEDLE INCAPACITATOR (NEEDLE GUARD)
K042907 · FMI
Pdmp, Inc.
General Hospital · 62d
Cleared Dec 22, 2004
DEPUY C-STEM AMT HIP PROSTHESIS
K042959 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 56d
Cleared Dec 22, 2004
QUANTEX MYOGLOBIN
K042982 · DDR
Instrumentation Laboratory CO
Chemistry · 54d
Cleared Dec 22, 2004
BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
K043038 · MEG
Biotop Technology Co., Ltd.
General Hospital · 48d
Cleared Dec 22, 2004
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K043056 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 47d
Cleared Dec 22, 2004
GE OEC FLUOROSTAR
K043076 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 44d
Cleared Dec 22, 2004
GORE POLYPROPYLENE HERNIA MESH
K043081 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 44d
Cleared Dec 22, 2004
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
K043158 · NBW
Bayer Healthcare, LLC
Chemistry · 37d
Cleared Dec 22, 2004
HEMOSIL RECOMBIPLASTIN
K043184 · GJS
Instrumentation Laboratory CO
Hematology · 35d