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
158377–158400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1982
ACCUSET ADMINISTRATION SET
K823346 · FPA
Imed Corp.
General Hospital · 21d
Cleared Nov 30, 1982
1512M/F WIRE ELECTRODE NEEDLE SET
K823432 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 14d
Cleared Nov 30, 1982
BALLOON THERMODILUTION CATHETER #7164&
K823433 · DYG
Critikon Company, LLC
Cardiovascular · 14d
Cleared Nov 30, 1982
MIKRO-TIP CATHETER PRESSURE TRANSDUCER
K823434 · DRF
Millar Instruments, Inc.
Cardiovascular · 14d
Cleared Nov 29, 1982
FLUOROSET IMMUNOFLUORESCENT ANTIBODY
K822785 · GQL
Immulok, Inc.
Microbiology · 76d
Cleared Nov 29, 1982
RAAF DUAL LUMEN CATHETER
K822849
Quinton, Inc.
Gastroenterology & Urology · 67d
Cleared Nov 29, 1982
RIGHT ARTERIAL CATHETER
K822910 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 59d
Cleared Nov 29, 1982
CLINISTAT TDA SERIES
K823112 · KHO
Miles Laboratories, Inc.
Toxicology · 39d
Cleared Nov 29, 1982
ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL
K823127 · LAZ
Syva Co.
Toxicology · 35d
Cleared Nov 29, 1982
ADVANCE EMIT CAD PROCAINAMIDE ASSAY
K823128 · LAR
Syva Co.
Chemistry · 35d
Cleared Nov 29, 1982
ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE
K823129 · LAN
Syva Co.
Chemistry · 35d
Cleared Nov 29, 1982
CELL SCRAPER
K823138 · KJA
Corning Costar Corp.
Hematology · 35d
Cleared Nov 29, 1982
OXYGEN MASKS
K823141 · BYG
Seven Harvest Intl. Import & Export
Anesthesiology · 35d
Cleared Nov 29, 1982
OXYGEN TUBINGS
K823142 · BYX
Seven Harvest Intl. Import & Export
Anesthesiology · 35d
Cleared Nov 29, 1982
BUBBLE HUMIDIFIERS
K823143 · BTT
Seven Harvest Intl. Import & Export
Anesthesiology · 35d
Cleared Nov 29, 1982
SINGLE STEP FREE-T4 125I RADIOIMMUNO-
K823144 · CEC
Corning Medical & Scientific
Chemistry · 35d
Cleared Nov 29, 1982
LIQUIZYME TOTAL PROTEIN REAGENT
K823170 · CEK
Amresco, Inc.
Chemistry · 34d
Cleared Nov 29, 1982
SPECIAL CONTROL SERUM FOR HDL-CHOLES
K823196 · JJK
Boehringer Mannheim Corp.
Chemistry · 34d
Cleared Nov 29, 1982
ENZYME-TEST DIGOXIN
K823199 · KXT
Icl Scientific
Chemistry · 34d
Cleared Nov 29, 1982
125 I-DEHYDROEPIANDROSTERONE SULFATE
K823200 · JKC
Wien Laboratories, Inc.
Chemistry · 34d
Cleared Nov 29, 1982
HUMAN PLACENTAL LACTOGEN KIT
K823201 · JMF
Diagnostic Products Corp.
Chemistry · 34d
Cleared Nov 29, 1982
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
K823212 · DJP
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Nov 29, 1982
SBA 300 CLINICAL CHEMISTRY ANALYZER
K823233 · JJC
Gilford Instrument Laboratories, Inc.
Chemistry · 31d
Cleared Nov 29, 1982
BARBITURATE TEST SET #0550-050
K823237 · DJN
Stanbio Laboratory
Toxicology · 28d