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
159217–159240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1982
FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB
K823063 · FRN
Travenol Laboratories, S.A.
General Hospital · 43d
Cleared Nov 30, 1982
INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT
K823108 · DTM
Extracorporeal Medical Specialities,...
Cardiovascular · 40d
Cleared Nov 30, 1982
AMBULATORY INSULIN INFUSION PUMP 9205
K823193 · FRN
Cpi, Inc.
General Hospital · 35d
Cleared Nov 30, 1982
BETATRON II
K823204 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 34d
Cleared Nov 30, 1982
INPERSOL PERITONEAL DIALSIS CYCLER SET
K823217 · FKX
Abbott Laboratories
Gastroenterology & Urology · 33d
Cleared Nov 30, 1982
CADIO-RESPIRATORY MONITOR #CR-2
K823312 · DRT
Electromed Intl., Ltd.
Cardiovascular · 25d
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