FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161737–161760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 02, 1981
ANERIOD GAUZE
K812932 · DXG
Abco Dealers, Inc.
Cardiovascular · 43d
Cleared Dec 02, 1981
RMI TRANSILLUMINATOR, MODEL 292
K812949 · HJM
Radiation Measurements, Inc.
Radiology · 42d
Cleared Dec 02, 1981
RESPOND II...NEUROMUSCULAR STIMULATOR
K813008 · IPF
Medtronic Vascular
Physical Medicine · 36d
Cleared Dec 02, 1981
HELIOSEAL
K813015 · EBC
Vivadent (Usa), Inc.
Dental · 36d
Cleared Dec 02, 1981
FUKUDA DENSHI CARDIMAX FK-12
K813022 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 36d
Cleared Dec 02, 1981
FUKUDA DENSHI CARDIMAX FK-11
K813023 · DSP
Brentwood Instruments, Inc.
Cardiovascular · 36d