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

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176,076 results
60841–60864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2006
PIPELINE II ACCESS SYSTEM
K062814 · GZT
Depuy Spine, Inc.
Neurology · 86d
Cleared Dec 15, 2006
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K063446 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 15, 2006
VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND...
K063478 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 28d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY...
K063591 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 14d
Cleared Dec 14, 2006
PULMOLIFE
K061283 · BZG
Micro Medical, Ltd.
Anesthesiology · 220d
Cleared Dec 14, 2006
INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K061901 · MRN
Ino Therapeutics
Anesthesiology · 162d
Cleared Dec 14, 2006
CELLSEARCH CIRCULATING TUMOR CELL KIT
K062013 · NQI
Veridex, LLC
Pathology · 150d
Cleared Dec 14, 2006
LAIMAD
K062333 · LRK
Steven Lamberg, D.D.S
Dental · 126d
Cleared Dec 14, 2006
FLOSIMPLE ARTHROSCOPY PUMP A120
K062380 · HRX
W.O.M. World of Medicine AG
Orthopedic · 121d
Cleared Dec 14, 2006
SUPRACOR BALLOON CATHETER
K062582 · DSP
Abiomed, Inc.
Cardiovascular · 105d
Cleared Dec 14, 2006
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
K062640 · HAW
Stryker Instruments
Neurology · 99d
Cleared Dec 14, 2006
RUIKE, MODEL 3331
K062676 · INI
Shanghai Ruike Sports Goods Co., Ltd.
Physical Medicine · 97d
Cleared Dec 14, 2006
COPILOT HEALTH MANAGEMENT SYSTEM
K062770 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 90d
Cleared Dec 14, 2006
PROTON THERAPY SYSTEM
K062891 · LHN
Indiana University Cyclotron Facility
Radiology · 79d
Cleared Dec 14, 2006
C-U2
K062897 · EIA
Cefla S.C.R.L.
Dental · 78d
Cleared Dec 14, 2006
HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES
K062947 · EFB
Peng Lim Enterprise Co., Ltd.
Dental · 77d
Cleared Dec 14, 2006
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
K062969 · FYA
Medline Industries, Inc.
General Hospital · 76d
Cleared Dec 14, 2006
INTAI BONE PLATE AND BONE SCREW SYSTEM
K063020 · HRS
Intai Technology, Inc.
Orthopedic · 73d
Cleared Dec 14, 2006
AIR-FLEX WITH AUTO-DISTRACTION
K063034 · JFB
Hill Laboratories Co.
Physical Medicine · 72d
Cleared Dec 14, 2006
APERFIX TIBIAL IMPLANT WITH INSERTER
K063070 · HWC
Cayenne Medical, Inc.
Orthopedic · 69d
Cleared Dec 14, 2006
E-CHECK (XE)
K063218 · JPK
Streck
Hematology · 51d
Cleared Dec 14, 2006
RPM RESPIRATORY GATING SYSTEM
K063270 · IYE
Varian Medical Systems, Inc.
Radiology · 45d
Cleared Dec 14, 2006
PRONTO V3 EXTRACTION CATHETER, MODEL 5003
K063371 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 36d
Cleared Dec 14, 2006
CROSSPLAN / ACCUSOFT-XL V.4.04
K063482 · MUJ
Direx Systems Corp.
Radiology · 27d