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

Filters: Cleared only ×
176,076 results
163801–163824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1981
KHI CPRAM BREATHING CIRCUIT
K811858 · CAI
Khi, Inc.
Anesthesiology · 15d
Cleared Jul 16, 1981
EASY-FLO ARTERIAL BLOOD GAS KIT
K811860 · CBT
Dhd Medical Products Div. Diemolding...
Anesthesiology · 15d
Cleared Jul 16, 1981
ARTHROSCOPIC LEG HOLDER
K811861 · HRX
Stryker Corp.
Orthopedic · 15d
Cleared Jul 16, 1981
SCENTED MENSTRUAL PADS
K811868 · HHL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 15d
Cleared Jul 16, 1981
UNSCENTED MENSTRUAL PADS
K811869 · HHD
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 15d
Cleared Jul 16, 1981
LEECO FERRITIN-QUANT DIAG. TEST KIT
K811880 · DBF
Leeco Diagnostics, Inc.
Immunology · 15d
Cleared Jul 16, 1981
IMV MANIFOLDS
K811908 · CBO
Airlife, Inc.
Anesthesiology · 15d
Cleared Jul 16, 1981
CARDIOPULMUNARY RESUSCITATOR
K811909 · DRM
Michigan Instruments, Inc.
Cardiovascular · 15d
Cleared Jul 16, 1981
VISITEC NEEDLE RANGE (ANESTHESIOLOGY)
K811963 · BSP
Visitec Co.
Anesthesiology · 6d
Cleared Jul 15, 1981
WATER PISTOL
K811594 · EIC
Aus-Tex Dental Mfg. & Design
Dental · 37d
Cleared Jul 15, 1981
SR-ISOCETTE
K811665 · ELK
J. Aderer, Inc.
Dental · 30d
Cleared Jul 15, 1981
COLTENE COLTEX/COLTOFLAX
K811666 · ELW
Coltene, Inc.
Dental · 30d
Cleared Jul 15, 1981
COLTENE PRESSURE SPOT INDICATOR
K811667 · ELW
Coltene, Inc.
Dental · 30d
Cleared Jul 15, 1981
DRUG STANDARDS
K811674 · DKB
Supelco, Inc.
Chemistry · 30d
Cleared Jul 15, 1981
ENTRI ENTERNAL FEEDING SET
K811683 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 15, 1981
GENTAMICIN REAGENT TEST KIT
K811692 · LCD
Beckman Instruments, Inc.
Toxicology · 30d
Cleared Jul 15, 1981
BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST
K811710 · LCP
Bio-Rad
Toxicology · 28d
Cleared Jul 15, 1981
PARA-PAK
K811722 · HYI
Meridian Diagnostics, Inc.
Toxicology · 27d
Cleared Jul 15, 1981
PORTABLE AUDIOMETERS
K811727 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 27d
Cleared Jul 15, 1981
FINETONE MODEL VI HEARING AID
K811751 · ESD
Vicon Instrument Co.
Ear, Nose, Throat · 23d
Cleared Jul 15, 1981
THERAPEUTIC DRUG CONTROL
K811756 · DIF
Icl Scientific
Toxicology · 23d
Cleared Jul 15, 1981
COLTENE PRESIDENT IMPRESSION MATERIALS
K811767 · ELW
Coltene, Inc.
Dental · 23d
Cleared Jul 15, 1981
AUDITORY LOCALIZER
K811772 · ETS
Western Advanced Technology, Inc.
Ear, Nose, Throat · 23d
Cleared Jul 15, 1981
OCTOTOXIC SCREENER
K811790 · ETS
Western Advanced Technology, Inc.
Ear, Nose, Throat · 21d