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
155113–155136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 1984
DOPPLER PHANTOM FLOW CONTROL SYS
K834481 · IXF
Radiation Measurements, Inc.
Radiology · 41d
Cleared Jan 25, 1984
TISSUE MIMICKING ULTRASOUND PHANTOMS
K834482 · IXF
Radiation Measurements, Inc.
Radiology · 41d
Cleared Jan 25, 1984
STERILE WET DRESSING PACK
K834532 · KDD
W.G. Whitney Corp.
General & Plastic Surgery · 35d
Cleared Jan 25, 1984
CRYSTALCONE FACE MASK-MED-W/HOOKRING
K834536 · BSJ
Warne Surgical Products, Ltd.
Anesthesiology · 34d
Cleared Jan 24, 1984
LABORATORY DATA MGMT SYSTEM SDMS
K831838 · JQP
Vickers America Medical Corp.
Chemistry · 231d
Cleared Jan 24, 1984
STAR HCG MONOCLONAL ANTIBODY IMMUNORAD
K832796 · JHI
Syncor Intl. Corp.
Chemistry · 159d
Cleared Jan 24, 1984
NEUROTRON 100
K833086 · GZJ
Neutro-Tronics
Neurology · 113d
Cleared Jan 24, 1984
TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN
K833402 · DEW
Technicon Instruments Corp.
Chemistry · 116d
Cleared Jan 24, 1984
IMMOPHASE D-TE 3 RADIOIMMUNOASSAY
K833406 · CGF
Corning Medical & Scientific
Chemistry · 116d
Cleared Jan 24, 1984
NATURELLE II & LITE II-N72-N74-L
K833774 · EJS
Jeneric Ind.
Dental · 89d
Cleared Jan 24, 1984
FILAFEX ESTHETIC ORTHODINIC WIRE
K833788 · DZC
Berkley and Co.
Dental · 85d
Cleared Jan 24, 1984
PHASE II THEOPHYLLINE RADIOIMMUNOASSAY
K833789 · LCA
Medical & Scientific Designs, Inc.
Chemistry · 85d
Cleared Jan 24, 1984
LYPHOCHEK THERAPEUTIC DRUG CONTROL
K833794 · DIF
Bio-Rad
Chemistry · 84d
Cleared Jan 24, 1984
URINE THC CANNABINOIDS DIRECT RIA KIT
K833911 · LAT
Immunalysis Corporation
Toxicology · 71d
Cleared Jan 24, 1984
COAT-A-COUNT NHS-PROLACTIN KIT AND
K833925 · CFT
Diagnostic Products Corp.
Chemistry · 71d
Cleared Jan 24, 1984
MICROLAB M DILUTER/DISPENSER
K833959 · JQW
Syva Co.
Toxicology · 69d
Cleared Jan 24, 1984
TECHNICON RA-1000 SYSTEM
K833992 · JGS
Technicon Instruments Corp.
Chemistry · 64d
Cleared Jan 24, 1984
BIO-SCIENCE LABORATORIES T4 REAGENT
K834023 · CDX
Biosan Laboratories, Inc.
Chemistry · 63d
Cleared Jan 24, 1984
CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT
K834052 · KLT
Abbott Laboratories
Toxicology · 62d
Cleared Jan 24, 1984
EMIT QST PHENOBARBITAL ASSAY
K834216 · DLZ
Syva Co.
Toxicology · 50d
Cleared Jan 24, 1984
THEOFAST TEST KIT FOR QUANTITATIVE THEO
K834244 · KLS
Allergenetics
Toxicology · 48d
Cleared Jan 24, 1984
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB
K834294 · LCP
Emd Chemicals, Inc.
Hematology · 47d
Cleared Jan 24, 1984
BEAR VENTI--VOICE
K834555 · ESE
Bear Medical Systems, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 24, 1984
C3 ANTISERUM CONTROL
K834604 · CZW
Technicon Instruments Corp.
Immunology · 116d