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
149809–149832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1985
LIQUA-SONIC GEL
K841871 · GYB
Chester Labs, Inc.
Neurology · 311d
Cleared Mar 14, 1985
AUTOFLUOR V SYSTEM
K842991 · DHN
Tech America Diagnostics
Immunology · 227d
Cleared Mar 14, 1985
ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS
K850334 · CHJ
Roche Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Mar 14, 1985
CONCEPT SUCTION SLEEVE
K850423 · HTZ
Concept, Inc.
General & Plastic Surgery · 38d
Cleared Mar 14, 1985
ARTHROSCOPY SUCTION BIOPSY PUNCH
K850527 · HTZ
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 35d
Cleared Mar 14, 1985
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M
K850586 · DAO
Applications Lab
Immunology · 29d
Cleared Mar 14, 1985
SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN
K850587 · DEM
Applications Lab
Immunology · 29d
Cleared Mar 14, 1985
SPECTRONIC 2000 SPECTROPHOTOMETER
K850767 · JJQ
Bausch & Lomb, Inc.
Chemistry · 17d
Cleared Mar 14, 1985
AMYLASE PRODUCTS
K850798 · JFJ
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Mar 13, 1985
GIBCO HERPES ID KIT
K841943 · GQL
Gibco Laboratories Life Technologies,...
Microbiology · 306d
Cleared Mar 13, 1985
CATH-TECH POLYURETHANE UMBILICAL VESS
K842577 · FOZ
Catheter Technology Corp.
General Hospital · 253d
Cleared Mar 13, 1985
IV ADMIN. SET FOR MVP 1 INFUSION PUMP
K843311 · FRN
Ziehm International, Inc.
General Hospital · 202d
Cleared Mar 13, 1985
VISITEC OPHTHALMIC FLUID DISTRIB- SET
K843487 · HQC
Visitec Co.
Ophthalmic · 188d
Cleared Mar 13, 1985
VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH
K844336 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 125d
Cleared Mar 13, 1985
VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA
K844433 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 117d
Cleared Mar 13, 1985
VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH
K844434 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 117d
Cleared Mar 13, 1985
PORTABLE DIAGNOSTIC LABORATORY
K844476 · LIB
Portable Medical Laboratories, Inc.
Chemistry · 114d
Cleared Mar 13, 1985
MOBILCHAIR 360 ELECTRIC-POWERED CHAIR
K844847 · ITI
Davis-Smith Corp.
Physical Medicine · 90d
Cleared Mar 13, 1985
CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M
K850183 · FRN
Deltec Systems, Inc.
General Hospital · 54d
Cleared Mar 13, 1985
BIO-TEK AUTOMATED MICROPLATE WASHER EL402
K850249 · JTC
Bio-Tek Instruments, Inc.
Microbiology · 50d
Cleared Mar 13, 1985
PHADEBACT MONOCLONAL GC TEST
K850351 · LIC
Pharmacia, Inc.
Microbiology · 44d
Cleared Mar 13, 1985
BIOTIS CHOCOLATE TELLURITE
K850565 · JSI
Otisville Biotech, Inc.
Microbiology · 29d
Cleared Mar 12, 1985
TSS/FIK
K842501
Zarcon Corp.
Immunology · 259d
Cleared Mar 12, 1985
SITE STRIP
K843200 · NAD
E-Med Corp.
General & Plastic Surgery · 210d