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
60433–60456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2007
VERSATILE 1 EZCARE WOUND VACUUM SYSTEM
K061919 · OMP
Blue Sky Medical Group Incorporated
General & Plastic Surgery · 214d
Cleared Feb 05, 2007
SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
K062098 · MHX
Datascope Corp.
Cardiovascular · 196d
Cleared Feb 05, 2007
DBX STRIP
K062205 · MBP
Musculoskeletal Transplant Foundation
Orthopedic · 188d
Cleared Feb 05, 2007
DERMOTHERAP GUN
K062339 · KZH
Dermoequipos S.R.L.
General Hospital · 179d
Cleared Feb 05, 2007
RUIKE, MODEL 3411
K062646 · INI
Shanghai Ruike Sports Goods Co., Ltd.
Physical Medicine · 154d
Cleared Feb 05, 2007
KODEA, MODELS XJ-2001AC
K062893 · DXN
Shanghai Kodea Economic and Trade...
Cardiovascular · 131d
Cleared Feb 05, 2007
SCIENT'X SPINAL SYSTEM
K062912 · MNI
Scient'X
Orthopedic · 131d
Cleared Feb 05, 2007
SONIC-STIM
K063135 · IMG
Naimco, Inc.
Physical Medicine · 112d
Cleared Feb 05, 2007
NIPRO BIOHOLE NEEDLE
K063368 · FIE
Nipro Medical Corp.
Gastroenterology & Urology · 90d
Cleared Feb 05, 2007
NISSIN PEDIATRIC SERIES WHEELCHAIR
K063521 · INM
Nissin Medical, Inc.
Physical Medicine · 75d
Cleared Feb 05, 2007
JUNIPER COOLING DEVICE XTRA
K063715 · GEX
Juniper Medical, Inc.
General & Plastic Surgery · 53d
Cleared Feb 05, 2007
CANDELA FLUORESCENT PULSED LIGHT SYSTEM
K063800 · GEX
Candela Corp.
General & Plastic Surgery · 45d
Cleared Feb 05, 2007
ZIPPREP ELECTRODE
K070069 · GXY
Aspect Medical Systems, Inc.
Neurology · 28d
Cleared Feb 05, 2007
CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT
K070297 · EFB
Dental Air Solutions of Nc, Inc.
Dental · 5d
Cleared Feb 02, 2007
STRYKER AUTO IRRIGATION SYSTEM
K061108 · FRN
Stryker
General Hospital · 288d
Cleared Feb 02, 2007
DELTA XTEND REVERSE SHOULDER SYSTEM
K062250 · PHX
DePuy Orthopaedics, Inc.
Orthopedic · 184d
Cleared Feb 02, 2007
MIRAGE LIBERTY FULL FACE MASK
K063011 · BZD
Resmed, Ltd.
Anesthesiology · 123d
Cleared Feb 02, 2007
MIRAGE QUATTRO FULL FACE MASK
K063122 · BZD
Resmed, Ltd.
Anesthesiology · 113d
Cleared Feb 02, 2007
DANA DIABECARE IIS
K063126 · LZG
Sooil Development Co., Ltd.
General Hospital · 112d
Cleared Feb 02, 2007
ACON DIGITAL THERMOMETER PROBE COVERS
K063418 · FLL
ACON Laboratories, Inc.
General Hospital · 81d
Cleared Feb 02, 2007
CERAMILL ZI
K063511 · EIH
Amann Girrbach America, Inc.
Dental · 74d
Cleared Feb 02, 2007
TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II...
K063515 · HRY
Biomet Manufacturing, Inc.
Orthopedic · 73d
Cleared Feb 02, 2007
CLEARFIL MAJESTY FLOW
K063593 · EBF
Kuraray America, Inc.
Dental · 60d
Cleared Feb 02, 2007
FIBULA PLATE PROLOCK WITH ANGULAR STABILITY
K063672 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 53d