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
162577–162600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1981
PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE
K813165 · BSP
Burron Medical Products, Inc.
Anesthesiology · 23d
Cleared Dec 03, 1981
LIQUIZYME GLUCOSE REAGENT
K813168 · CGA
American Research Products Co.
Chemistry · 17d
Cleared Dec 03, 1981
CELESTIN PULSION ESOPHOGEAL PROSTHESIS
K813169 · KNT
Inmed Corp.
Gastroenterology & Urology · 21d
Cleared Dec 03, 1981
PHENYLALANINE UV KINETIC TEST KIT
K813171 · JNB
Biochemicals, Inc.
Chemistry · 17d
Cleared Dec 03, 1981
PERICAN, EPIDURAL CANNULA
K813179 · BSP
Burron Medical Products, Inc.
Anesthesiology · 21d
Cleared Dec 03, 1981
PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO
K813186 · CAZ
Burron Medical Products, Inc.
Anesthesiology · 17d
Cleared Dec 03, 1981
SHIGELLA SERA-CHEK
K813191 · LIA
Lab Ability, Inc.
Microbiology · 16d
Cleared Dec 03, 1981
C-TERMINAL PTH RIA TEST KIT, DSL-1000
K813203 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 20d
Cleared Dec 03, 1981
GEL FLOTATION CUSHION
K813225 · KIC
Jefferson Industries, Inc.
Physical Medicine · 23d
Cleared Dec 03, 1981
COOKED MEAT MEDIUM
K813232 · JSG
Oxoid U.S.A., Inc.
Microbiology · 16d
Cleared Dec 03, 1981
EPICAN EPIDURAL CANNULA, BEVEL ACCORD
K813236 · BSP
Burron Medical Products, Inc.
Anesthesiology · 23d
Cleared Dec 03, 1981
EMIT-AAD THEOPHYLLINE ASSAY
K813240 · LER
Syva Co.
Toxicology · 16d
Cleared Dec 03, 1981
EMIT-AAD THEOPHYLLINE CONTROL
K813241 · LAS
Syva Co.
Toxicology · 16d
Cleared Dec 03, 1981
KANESON/COMFORT PLUS MANUAL BREAST PUMP
K813247 · HGY
Marshall Electronics, Inc.
Obstetrics & Gynecology · 15d
Cleared Dec 03, 1981
HELP-MATE
K813249 · ESD
G & W Applied Science Laboratories
Ear, Nose, Throat · 15d
Cleared Dec 03, 1981
TWO PIECE OSTOMY SYSTEM
K813269 · EXB
Hollister, Inc.
Gastroenterology & Urology · 13d
Cleared Dec 02, 1981
SIEMENS-ELEMA PSA 376
K812104 · DTA
Siemens Corp.
Cardiovascular · 131d
Cleared Dec 02, 1981
L.O.N. REUSABLE MANIFOLDS & STOPCOCKS
K812407 · DTL
L.O.N. Research, Inc.
Cardiovascular · 103d
Cleared Dec 02, 1981
L.O.N. DISPOSABLE CORONARY MANIFOLD
K812408 · DTL
L.O.N. Research, Inc.
Cardiovascular · 103d
Cleared Dec 02, 1981
HEAD PROTECTOR
K812473 · FMQ
Maddak, Inc.
General Hospital · 93d
Cleared Dec 02, 1981
KOI BLUE FIELD ENTOPTOSCOPE
K812764 · HKL
Koi, Inc.
Ophthalmic · 61d
Cleared Dec 02, 1981
I.V.E. REFRACTION SYSTEM
K812896 · HKO
Bausch & Lomb, Inc.
Ophthalmic · 48d
Cleared Dec 02, 1981
PE-01 ELECTRONIC INFUSION PUMP
K812898 · FRN
Egnell, Inc.
General Hospital · 47d
Cleared Dec 02, 1981
EVENT MASTER
K812920 · DSH
Instruments For Cardiac Research
Cardiovascular · 44d