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
67825–67848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 2004
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K042541 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 22d
Cleared Oct 12, 2004
TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K042561 · LNS
Fmd, LLC
Gastroenterology & Urology · 21d
Cleared Oct 12, 2004
BIOMEDIX PADNET LAB
K042616 · JOM
Biomedix, Inc.
Cardiovascular · 19d
Cleared Oct 12, 2004
CYBIRD LED CURING LIGHT
K042703 · EBZ
Dxm Co., Ltd.
Dental · 12d
Cleared Oct 08, 2004
LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25...
K040563 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 219d
Cleared Oct 08, 2004
THE FUGO BLADE FOR GLAUCOMA
K041019 · NCR
Medisurg , Ltd.
Ophthalmic · 171d
Cleared Oct 08, 2004
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
K041353 · MEH
Jri Manufacturing, Ltd.
Orthopedic · 141d
Cleared Oct 08, 2004
ABL800 FLEX
K041874 · CHL
Radiometer Medical Aps
Chemistry · 88d
Cleared Oct 08, 2004
ACU-STRAP MOTION SICKNESS BAND
K041877 · MVV
Health Ent., Inc.
Neurology · 88d
Cleared Oct 08, 2004
T2 PROXIMAL HUMERAL NAIL
K042396 · HSB
Howmedica Osteonics Corp.
Orthopedic · 36d
Cleared Oct 08, 2004
MIRAGE SWIFT
K042403 · BZD
Resmed, Ltd.
Anesthesiology · 35d
Cleared Oct 08, 2004
IQQA-CHEST SOFTWARE PACKAGE
K042408 · OMJ
Edda Technology, Inc.
Radiology · 35d
Cleared Oct 08, 2004
BAXJECT II
K042410 · LHI
Baxter Healthcare Corp
General Hospital · 31d
Cleared Oct 08, 2004
ATHENA MULTI-LYTE ANA-II TEST SYSTEM
K042416 · LKJ
Zeus Scientific, Inc.
Immunology · 31d
Cleared Oct 08, 2004
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
K042419 · BSZ
Draeger Medical, Inc.
Anesthesiology · 31d
Cleared Oct 08, 2004
DORSAL INTRAMEDULLARY PLATE
K042437 · HRS
Deo Volente Orthopaedics, LLC
Orthopedic · 30d
Cleared Oct 08, 2004
BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS
K042517 · JEY
Linvatec Biomaterials, Ltd.
Dental · 23d
Cleared Oct 08, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042524 · KWP
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Oct 08, 2004
AUTO THERM 390, MODEL ME 390
K042554 · IMJ
Mettler Electronics Corp.
Physical Medicine · 18d
Cleared Oct 08, 2004
COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K042605 · NWE
Siemens AG Medical Solutions
Radiology · 14d
Cleared Oct 08, 2004
WIDE 1MP LCD MONITOR SYSTEM
K042634 · LLZ
Wide Corporation
Radiology · 11d
Cleared Oct 08, 2004
MEDLINE STRIDER MIDI 4
K042764 · INI
Medline Industries, Inc.
Physical Medicine · 3d
Cleared Oct 07, 2004
GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
K041005 · KDI
Gambro Renal Products
Gastroenterology & Urology · 171d
Cleared Oct 07, 2004
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
K041163 · FIP
Isopure, Corp.
Gastroenterology & Urology · 157d