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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
69889–69912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2003
AUDICOR UPGRADE SYSTEM
K032145 · DPS
Inovise Medical, Inc.
Cardiovascular · 109d
Cleared Oct 31, 2003
ZOLL M SERIES NIBP OPTION
K032363 · DXN
Zoll Medical Corp
Cardiovascular · 92d
Cleared Oct 31, 2003
BONE CEMENT RADIO-OPACIFIER
K032388 · MYU
Cardinalhealth
Neurology · 88d
Cleared Oct 31, 2003
PLUS PIVOT LINK UNIVERSAL SYSTEM
K032398 · MNI
Spine Vision, Inc.
Orthopedic · 88d
Cleared Oct 31, 2003
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
K032426 · DTK
Cook, Inc.
Cardiovascular · 86d
Cleared Oct 31, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT
K032527 · MQP
Implex Corp.
Orthopedic · 77d
Cleared Oct 31, 2003
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
K032564 · LAN
Dade Behring, Inc.
Chemistry · 72d
Cleared Oct 31, 2003
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
K032573 · LAR
Dade Behring, Inc.
Chemistry · 72d
Cleared Oct 31, 2003
VITEK GRAM NEGATIVE GATIFLOXACIN
K032711 · LON
bioMerieux, Inc.
Microbiology · 59d
Cleared Oct 31, 2003
VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
K032738 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Oct 31, 2003
VITEK 2 GRAM POSITIVE LINEZOLID
K032766 · LON
bioMerieux, Inc.
Microbiology · 56d
Cleared Oct 31, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS
K032993 · JJX
Ortho-Clinical Diagnostics, Inc.
Microbiology · 36d
Cleared Oct 31, 2003
MODIFICATION TO GLOBALCARDIO
K033037 · DSH
Cardiocomm Solutions, Inc.
Cardiovascular · 32d
Cleared Oct 31, 2003
IONOFIL COLOR AC
K033068 · EMA
Voco GmbH
Dental · 32d
Cleared Oct 31, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
K033127 · JJX
Ortho-Clinical Diagnostics
Microbiology · 31d
Cleared Oct 31, 2003
PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
K033130 · DTE
Osypka Medical, Inc.
Cardiovascular · 31d
Cleared Oct 31, 2003
FUKUDA DENSHI MODEL FF SONIC UF-750XT
K033209 · IYN
Fukuda Denshi USA, Inc.
Radiology · 28d
Cleared Oct 31, 2003
PHERON PTA CATHETER
K033217 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared Oct 31, 2003
K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT
K033263 · ITI
Track Corporation
Physical Medicine · 22d
Cleared Oct 31, 2003
MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL...
K033264 · DWF
Medtronic Perfusion Systems
Cardiovascular · 22d
Cleared Oct 31, 2003
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
K033305 · DSI
Draeger Medical Systems, Inc.
Cardiovascular · 17d
Cleared Oct 30, 2003
DBB-05 HEMODIALYSIS DELIVERY SYSTEM
K023509 · KDI
Davita Clinical Research (Trri)
Gastroenterology & Urology · 377d
Cleared Oct 30, 2003
POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851
K030082 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 294d
Cleared Oct 30, 2003
RATIONAL IMAGING PACS
K031473 · LLZ
Intuitive Imaging Informatics, LLC
Radiology · 174d