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
150409–150432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 1985
IN THE EAR MODEL X-ITE 84
K844985 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 23, 1985
SYVA ADVANCE EMIT PHENYTOIN ASSAY
K844990 · LES
Syva Co.
Toxicology · 28d
Cleared Jan 23, 1985
EMIT PHENYTOIN ASSAY
K844991 · DIP
Syva Co.
Toxicology · 28d
Cleared Jan 23, 1985
HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE
K850014 · EBH
Medi-Dent American, Inc.
Dental · 21d
Cleared Jan 23, 1985
TOWEL PACK, SURGICAL
K850016
East Texas Lighthouse For the Blind
General & Plastic Surgery · 21d
Cleared Jan 22, 1985
MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER
K844132 · LMB
Sigma Teleproducts, Inc.
Radiology · 91d
Cleared Jan 22, 1985
INFUSART
K844227 · FLN
Sartorius, Inc.
General Hospital · 82d
Cleared Jan 22, 1985
IV RATEMETER
K844309 · FLN
Aci Medical, Inc.
General Hospital · 77d
Cleared Jan 22, 1985
INFUSET W/HUBER NEEDLE
K844313 · FMI
Med Fusion Systems, Inc.
General Hospital · 77d
Cleared Jan 22, 1985
TITERTEK MICROPLATE WASHER 120
K844500 · JTC
Flow Laboratories, Inc.
Microbiology · 63d
Cleared Jan 22, 1985
DR-2C
K844650 · DXJ
General Devices
Cardiovascular · 54d
Cleared Jan 22, 1985
TITMUS VISION TESTER II
K844694 · HIT
Titmus Optical, Inc.
Ophthalmic · 50d
Cleared Jan 22, 1985
VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
K844715 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 56d
Cleared Jan 22, 1985
NEPHROSS ALLEGRO H.F.
K844748 · FKQ
Organon Teknika Corp.
Gastroenterology & Urology · 47d
Cleared Jan 22, 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
K844792 · FRN
Pacesetter Systems
General Hospital · 43d
Cleared Jan 22, 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504
K844851 · FRN
Pacesetter Systems
General Hospital · 40d
Cleared Jan 22, 1985
CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
K844898 · HKI
Canon USA, Inc.
Ophthalmic · 36d
Cleared Jan 22, 1985
HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2
K850070 · DXN
Healthcheck Corp.
Cardiovascular · 18d
Cleared Jan 18, 1985
MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
K841190 · GQL
Syva Co.
Microbiology · 303d
Cleared Jan 18, 1985
BIOMATT-1
K841392 · BZQ
Biorec Us, Inc.
Anesthesiology · 290d
Cleared Jan 18, 1985
TRANSVENOUS TINED VENTRICULAR/ATRIAL
K842031 · DTB
Medtronic Vascular
Cardiovascular · 245d
Cleared Jan 18, 1985
MODELS 4012/4512 TRANSVENOUS TINED-
K842032 · DTB
Medtronic Vascular
Cardiovascular · 245d
Cleared Jan 18, 1985
EPICARDIAL, UNIPOLAR LEAD 4951
K842065 · DTD
Medtronic Vascular
Cardiovascular · 241d
Cleared Jan 18, 1985
4A
K842122 · CBK
Life Products, Inc.
Anesthesiology · 234d