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
58417–58440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2007
SCANSCOPE XT SYSTEM
K071128 · NOT
Aperio Technologies
Pathology · 170d
Cleared Oct 10, 2007
PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040
K071484 · EMA
Glustitch, Inc.
Dental · 133d
Cleared Oct 10, 2007
ARROW INTERNATIONAL, INC., SURGICAL DRAPES
K071491 · KKX
Arrow Intl., Inc.
General Hospital · 133d
Cleared Oct 10, 2007
BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
K071638 · DZE
BioHorizons Implant Systems, Inc.
Dental · 117d
Cleared Oct 10, 2007
MIRAGE MICRO
K071808 · BZD
Resmed, Ltd.
Anesthesiology · 100d
Cleared Oct 10, 2007
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
K072113 · KGN
Integra Lifesciences Corp.
General & Plastic Surgery · 70d
Cleared Oct 10, 2007
MAGNETOM VERIO
K072237 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Oct 10, 2007
MASTERSCREEN & OXYCON CPX
K072323 · BZC
Viasys Healthcare GmbH
Anesthesiology · 51d
Cleared Oct 10, 2007
CARDIOP-B SYSTEM, VERSION 2.1
K072591 · IZI
Paieon, Inc.
Radiology · 26d
Cleared Oct 10, 2007
SHARPS AWAY DISPOSABLE CONTAINER
K072667 · MMK
Solutions, Inc.
General Hospital · 19d
Cleared Oct 09, 2007
LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM...
K063705 · NDW
Thermo Electron OY
Toxicology · 300d
Cleared Oct 09, 2007
MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901
K071384 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 145d
Cleared Oct 09, 2007
PROBE HOLDER SYSTEM
K071405 · LKF
Intuitive Surgical, Inc.
Obstetrics & Gynecology · 141d
Cleared Oct 09, 2007
DCA VANTAGE, MODEL 5075
K071466 · LCP
Siemens Medical Solutions Diagnostics
Chemistry · 133d
Cleared Oct 09, 2007
RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES
K071621 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 117d
Cleared Oct 09, 2007
TRIATHLON PKR SYSTEM
K071881 · HRY
Howmedica Osteonics Corp.
Orthopedic · 92d
Cleared Oct 05, 2007
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
K063131 · KLT
Thermo Electron OY
Toxicology · 357d
Cleared Oct 05, 2007
POLYPERF / POLYPERF SAFE
K063631 · FPA
Laboratoires Perouse
General Hospital · 303d
Cleared Oct 05, 2007
IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
K070354 · BSP
International Medical Development, Inc.
Anesthesiology · 241d
Cleared Oct 05, 2007
INTRACEPT BI-POLAR RF PROBE, MODEL 04814
K070443 · GEI
Relievant Medsystems, Inc.
General & Plastic Surgery · 232d
Cleared Oct 05, 2007
SMALL BONE WEDGE
K070592 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 217d
Cleared Oct 05, 2007
VHP 136 TRAY
K070769 · KCT
STERIS Corporation
General Hospital · 199d
Cleared Oct 05, 2007
ELECSYS CORTISOL TEST SYSTEM
K070788 · NHG
Roche Diagnostics
Chemistry · 197d
Cleared Oct 05, 2007
ICU MEDICAL SINGLE-USE SYRINGE
K070856 · FMF
Icu Medical, Inc.
General Hospital · 191d