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

Filters: Cleared only ×
175,820 results
139585–139608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1987
CLEARFIL POSTERIOR 3
K871635 · EBF
Kuraray Co.
Dental · 80d
Cleared Jul 16, 1987
NEUROCOM PRESSURE TEST SYSTEM
K871652 · ETY
Neurocom International, Inc.
Ear, Nose, Throat · 79d
Cleared Jul 16, 1987
NICOLET AMP 6R11 SYSTEM
K871678 · GWL
Nicolet Biomedical Instruments
Neurology · 79d
Cleared Jul 16, 1987
ALTERNARIA TENUIS ALLERGEN DISC
K871684 · DHB
Incstar Corp.
Immunology · 78d
Cleared Jul 16, 1987
VAS-CATH PERITONEAL DIALYSIS CATHETER
K871817 · FJS
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 66d
Cleared Jul 16, 1987
V-MARC 88A COMPUTER
K871853 · JQP
V.Marc, A Div. of Pictorial, Inc.
Chemistry · 65d
Cleared Jul 16, 1987
UROVIEW
K872022 · KQS
Oec-Diasonics, Inc.
Gastroenterology & Urology · 51d
Cleared Jul 16, 1987
CARBON ELECTRODE
K872044 · GXY
Futuremed Div. of Future Impex Corp.
Neurology · 50d
Cleared Jul 16, 1987
SPERM WASHING MEDIUM #9932
K872102 · HDR
Irvine Scientific
Obstetrics & Gynecology · 45d
Cleared Jul 16, 1987
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES
K872130 · JHI
Syva Co.
Chemistry · 44d
Cleared Jul 16, 1987
PORTABLE DENTAL X-RAY UNIT MODEL 4000
K872240 · EHD
Home/Office Dental, Inc.
Radiology · 35d
Cleared Jul 16, 1987
CHOLESTEROL REAGENT
K872295 · CHH
Sigma Diagnostics, Inc.
Chemistry · 30d
Cleared Jul 16, 1987
DYNATECH SPD 3000, #002-900-0000
K872363 · JQW
Dynatech Laboratories, Inc.
Chemistry · 28d
Cleared Jul 16, 1987
VICE OR BENCH VICE
K872385 · LSA
Med-Tool, Inc.
General & Plastic Surgery · 27d
Cleared Jul 16, 1987
STANDARD SCREW DRIVER
K872387 · LRZ
Med-Tool, Inc.
General & Plastic Surgery · 27d
Cleared Jul 16, 1987
1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS
K872491 · GEG
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 23d
Cleared Jul 16, 1987
HEARING AID S45 SERIES
K872553 · ESD
Electone, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 16, 1987
HEARING AID 49 SERIES
K872554 · ESD
Electone, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 16, 1987
HEARING AID M35/M36 SERIES
K872556 · ESD
Electone, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 16, 1987
HDL CHOLESTEROL REAGENT
K872575 · CHH
Sigma Chemical Co.
Chemistry · 16d
Cleared Jul 16, 1987
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM
K872582 · LDM
Millipore Corp.
Chemistry · 16d
Cleared Jul 16, 1987
LEAD GLASS SHIELDS
K872656 · IWR
Viox Corp.
Radiology · 9d
Cleared Jul 15, 1987
ULTRASOUND TRANSDUCER GEL, STERILE
K871565 · JOT
Amedic USA
General & Plastic Surgery · 84d
Cleared Jul 15, 1987
HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES
K871577 · HDR
Irvine Scientific
Obstetrics & Gynecology · 83d