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
60649–60672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2007
PORTLAND COBALT CHROME FEMORAL HEAD
K063278 · JDI
Portland Orthopaedics Limited
Orthopedic · 73d
Cleared Jan 12, 2007
RELIANCE CI PROCESS INDICATOR
K063285 · JOJ
Albert Browne , Ltd.
General Hospital · 73d
Cleared Jan 12, 2007
TRU-CABLE
K063309 · FFS
Truphatek International, Ltd.
Gastroenterology & Urology · 71d
Cleared Jan 12, 2007
SPY IMAGING SYSTEM
K063345 · IZI
Novadaq Technologies, Inc.
Radiology · 67d
Cleared Jan 12, 2007
CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
K063370 · KWD
Arthrosurface, Inc.
Orthopedic · 65d
Cleared Jan 12, 2007
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
K063409 · NBW
Agamatrix
Chemistry · 60d
Cleared Jan 12, 2007
NEATSTITCH NEATCLOSE SUTURING DEVICE
K063462 · GAM
Neat Stitch , Ltd.
General & Plastic Surgery · 58d
Cleared Jan 12, 2007
MERON PLUS
K063554 · EMA
Voco GmbH
Dental · 46d
Cleared Jan 12, 2007
ACL TOP
K063679 · GKP
Instrumentation Laboratory CO
Hematology · 32d
Cleared Jan 12, 2007
NIPRO SAFETOUCH II GAMMA
K063721 · FIE
Nipro Medical Corp.
Gastroenterology & Urology · 28d
Cleared Jan 12, 2007
POWER EXTENDERS MODEL# PEC200, PES200,PES200S
K063746 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 25d
Cleared Jan 12, 2007
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS...
K063747 · MSH
Inovel, LLC
General Hospital · 24d
Cleared Jan 12, 2007
STRAUMANN PREFGEL
K063812 · KJJ
Straumann USA
Dental · 21d
Cleared Jan 12, 2007
SYNGO MI APPLICATIONS 2007A
K063826 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Jan 11, 2007
PORTABLE X-RAY SYSTEM, MODEL PORT-X II
K063121 · EHD
Genoray Co., Ltd.
Radiology · 91d
Cleared Jan 11, 2007
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN...
K063255 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 76d
Cleared Jan 11, 2007
HEARTSTART MRX, MODELS M3535A OR M3536A
K063375 · MKJ
Philips Medical Systems
Cardiovascular · 64d
Cleared Jan 11, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML
K063573 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Jan 11, 2007
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND...
K063610 · DEM
Dade Behring, Inc.
Immunology · 38d
Cleared Jan 11, 2007
VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE
K063623 · LON
bioMerieux, Inc.
Microbiology · 36d
Cleared Jan 11, 2007
CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
K063644 · FZP
Cardica, Inc.
General & Plastic Surgery · 35d
Cleared Jan 10, 2007
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
K061613 · NQN
Tripath Imaging
Pathology · 215d
Cleared Jan 10, 2007
RELIEF ACP ORAL CARE GEL
K062176 · LBH
Discus Dental, Inc.
Dental · 163d
Cleared Jan 10, 2007
INSUFLOW DEVICE, MODEL 6198
K063546 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 47d