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
79489–79512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2001
ORACLE ORAL MASK
K003894 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 189d
Cleared Jun 25, 2001
COCAINE DIPSTICK TEST, MODEL D747-A
K010239 · DIO
Teco Diagnostics
Toxicology · 151d
Cleared Jun 25, 2001
WAKO AUTOKIT C4
K010325 · DBI
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
WAKO AUTOKIT C3
K010326 · CZW
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
WAKO LIPID CALIBRATOR
K010334 · JIT
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
INTER-VIAL
K010703 · LHI
Duoject Medical Systems, Inc.
General Hospital · 108d
Cleared Jun 25, 2001
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
K010921 · LDJ
Advantage Diagnostics Corp.
Toxicology · 90d
Cleared Jun 25, 2001
SEP-10S PLUS, AND SP-12S PRO.
K010937 · FRN
Viltechmeda
General Hospital · 88d
Cleared Jun 25, 2001
QUELL DESENSITIZER
K010957 · LBH
Jeneric/Pentron, Inc.
Dental · 87d
Cleared Jun 25, 2001
BRACHYSEED PD-103 MODELS #PD1
K011119 · KXK
Draximage, Inc.
Radiology · 74d
Cleared Jun 25, 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · JFJ
Roche Diagnostics Corp.
Chemistry · 91d
Cleared Jun 25, 2001
ICS MEDICAL CHARTR OAE WITH TYMP
K011181 · EWO
Ics Medical Corp.
Ear, Nose, Throat · 68d
Cleared Jun 25, 2001
PORTABELL, MODEL 4200
K011222 · EIA
Bell Dental Products, LLC
Dental · 66d
Cleared Jun 25, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226 · JIX
Roche Diagnostics Corp.
Chemistry · 66d
Cleared Jun 25, 2001
ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM
K011245 · DZE
Sulzer Dental, Inc.
Dental · 63d
Cleared Jun 25, 2001
PHASE II GBM IGG ANTIBODY EIA TEST
K011348 · MVJ
Scimedx Corp.
Immunology · 54d
Cleared Jun 25, 2001
MICRODOSE CATH, MODELS 90121-201, -202, -203
K011383 · ETD
Durect Corp.
Ear, Nose, Throat · 49d
Cleared Jun 25, 2001
IL TEST PROS
K011424 · GGP
Instrumentation Laboratory CO
Hematology · 47d
Cleared Jun 25, 2001
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
K011720 · CIX
Olympus America, Inc.
Chemistry · 21d
Cleared Jun 22, 2001
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
K002427 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 318d
Cleared Jun 22, 2001
MAR COR SERVICES SEMPER PURE RO MACHINE
K003877 · FIP
Mar Cor Services, Inc.
Gastroenterology & Urology · 189d
Cleared Jun 22, 2001
CHESS HAND SURGERY SYSTEM
K010184 · MDM
Canica Design, Inc.
General & Plastic Surgery · 154d
Cleared Jun 22, 2001
POWDER FREE NITRILE EXAMINATION GLOVES
K010233 · LZA
P.T. Healthcare Glovindo
General Hospital · 149d
Cleared Jun 22, 2001
ML BLADE, MODEL ML7030
K010872 · HNO
Med-Logics, Inc.
Ophthalmic · 91d