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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
149401–149424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1985
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO
K850574 · JJY
American Dade
Immunology · 58d
Cleared Apr 12, 1985
TOTAL HIGE ENZYME IMMUNOASSAY
K850786 · DGC
Nms Pharmaceuticals, Inc.
Immunology · 45d
Cleared Apr 12, 1985
TACTILE PLUS DENTAL ELEVATORS
K850906 · EMJ
Ipco Corp.
Dental · 38d
Cleared Apr 12, 1985
MEDIX VISUAL URINE HCG (7/7) TEST
K850949 · JHI
Medix Biotech, Inc.
Chemistry · 36d
Cleared Apr 12, 1985
HFF GENCELLS
K850990 · KIT
Bioassay Systems Research Corp.
Hematology · 32d
Cleared Apr 12, 1985
EMIT QST PROCAINAMIDE ASSAY
K851061 · LAR
Syva Co.
Toxicology · 28d
Cleared Apr 12, 1985
PHARMACIA INSULIN RIA
K851071 · CFP
Pharmacia, Inc.
Chemistry · 25d
Cleared Apr 12, 1985
MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES
K851089 · FMF
Sherwood Medical Co.
General Hospital · 25d
Cleared Apr 12, 1985
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE
K851090 · FMF
Sherwood Medical Co.
General Hospital · 25d
Cleared Apr 12, 1985
BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET
K851101 · FOZ
Bionomy, Inc.
General Hospital · 24d
Cleared Apr 12, 1985
PACKETS FOR PREP. OF DIALYSATES & INFUSATES -
K851188 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 43d
Cleared Apr 12, 1985
PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS
K851355 · HEB
Intl. Playtex, Inc.
Obstetrics & Gynecology · 8d
Cleared Apr 12, 1985
PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS
K851356 · HEB
Intl. Playtex, Inc.
Obstetrics & Gynecology · 8d
Cleared Apr 12, 1985
HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2
K851379 · FLL
Healthcheck Corp.
General Hospital · 4d
Cleared Apr 11, 1985
AIRVIT MODEL 8500
K843594 · HQE
Lasermed Corp.
Ophthalmic · 211d
Cleared Apr 11, 1985
BRAIN FUNCTION MAPPING OPTION FOR PATHF
K843598 · GWK
Nicolet Biomedical Instruments
Neurology · 211d
Cleared Apr 11, 1985
SIEMENS SIRECUST 404N NEONATAL MONITOR
K844187 · DRT
Siemens Medical Solutions USA, Inc.
Cardiovascular · 164d
Cleared Apr 11, 1985
CARDIOSTAT 1 ECG RECORDER
K844392 · DPS
Siemens Elema AB
Cardiovascular · 149d
Cleared Apr 11, 1985
CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE
K850107 · GXZ
Nicolet Biomedical Instruments
Neurology · 91d
Cleared Apr 11, 1985
EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG
K850108 · GXY
Nicolet Biomedical Instruments
Neurology · 91d
Cleared Apr 11, 1985
ELECTROENCEPHALOGRAPH EEG
K850259 · GWQ
Nicolet Biomedical Instruments
Neurology · 79d
Cleared Apr 11, 1985
VIGGO CONNECTA 3-WAY INFUSION STOPCOCK
K850280 · FMG
Viggo Products
General Hospital · 78d
Cleared Apr 11, 1985
VIGGO SECALON T CATHETER
K850460 · FOZ
Viggo Products
General Hospital · 64d
Cleared Apr 11, 1985
IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH
K851296 · DTB
Telectronics, Inc.
Cardiovascular · 10d