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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
140281–140304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1987
AVL MODEL 985 ELECTROLYTE ANALYZER
K870657 · CEM
Avl Scientific Corp.
Chemistry · 83d
Cleared May 12, 1987
NEY-ORO 41
K870677 · EJT
Deringer-Ney, Inc.
Dental · 82d
Cleared May 12, 1987
CONTACT LENS TWEEZERS
K871130 · KYE
S. M. C. Medi-Tech Corp.
Ophthalmic · 53d
Cleared May 12, 1987
HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE
K871135 · LDD
First Medical Devices Corp.
Cardiovascular · 53d
Cleared May 12, 1987
HEARTSTART 2000, MANUAL DEFIBRILLATOR
K871136 · LDD
First Medical Devices Corp.
Cardiovascular · 53d
Cleared May 12, 1987
PLAYTEX TAMPONS AND DEODORANT TAMPONS
K871197 · HIL
Intl. Playtex, Inc.
Obstetrics & Gynecology · 49d
Cleared May 12, 1987
ACU-PREG-AL SLIDE TEST
K871294 · JHJ
Papibris Scientific, Inc.
Chemistry · 42d
Cleared May 12, 1987
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
K871329 · LCD
Em Diagnostic Systems, Inc.
Toxicology · 39d
Cleared May 12, 1987
CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO
K871412 · DRX
Contour Electrodes, Inc.
Cardiovascular · 34d
Cleared May 12, 1987
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
K871638 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared May 12, 1987
TAMPAX TAMPON, REGULAR
K871642 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 15d
Cleared May 12, 1987
DELFIA (TM) HTSH KIT
K871644 · JLW
Lkb Instruments, Inc.
Chemistry · 15d
Cleared May 12, 1987
GLUCOSE ENZYME - COLOR REAGENT SET
K871650 · CGA
Biochemical Trade, Inc.
Chemistry · 14d
Cleared May 12, 1987
COLORIMETRIC BUN REAGENT KIT
K871651 · CDL
Biochemical Trade, Inc.
Chemistry · 14d
Cleared May 12, 1987
CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS
K871677 · JHY
Catachem, Inc.
Chemistry · 14d
Cleared May 11, 1987
RAPIDEX BIOLOGICAL SURFACTANT
K862282 · FLG
Rapidex of London
General Hospital · 329d
Cleared May 11, 1987
APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)
K864260 · DRX
Grandcor Medical Systems
Cardiovascular · 194d
Cleared May 11, 1987
CARDIAC PERFORMANCE MONITOR
K864583 · DQK
Vascular Technology Incorporated
Cardiovascular · 172d
Cleared May 11, 1987
3MHZ ANNULAR ARRAY
K864980 · JOP
Philips Ultrasound, Inc.
Cardiovascular · 140d
Cleared May 11, 1987
RECORD KEEPING/DATA MANAGEMENT SYSTEM
K865035 · DQK
Critical Care Systems, Inc.
Cardiovascular · 139d
Cleared May 11, 1987
SINGLE LUMEN ACUTE CATHETER
K870328 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 103d
Cleared May 11, 1987
IVR-SP CUSTOM ANGIOGRAPHY TRAY
K870419 · DQO
North Coast Medi-Tek
Cardiovascular · 97d
Cleared May 11, 1987
GASTROINTESTINAL TUBE
K870508 · KNT
Penn Medical Devices, Inc.
Gastroenterology & Urology · 95d
Cleared May 11, 1987
OMEGA SILICONE CHIN IMPLANT
K871070 · FWP
Omega Silicone, Inc.
General & Plastic Surgery · 54d