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
70633–70656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2003
GLIDESHEATH
K033681 · DYB
Terumo Corp.
Cardiovascular · 17d
Cleared Dec 11, 2003
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K033708 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 15d
Cleared Dec 11, 2003
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE...
K033714 · DTN
Dideco S.P.A.
Cardiovascular · 15d
Cleared Dec 10, 2003
TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
K031949 · DXF
Baylis Medical Co., Inc.
Cardiovascular · 169d
Cleared Dec 10, 2003
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
K032719 · LIH
Gemore Technology Co, Ltd.
Neurology · 99d
Cleared Dec 10, 2003
GEM-STIM TENS, MODELS GM3XY AND GM3AXY
K032720 · GZJ
Gemore Technology Co, Ltd.
Neurology · 99d
Cleared Dec 10, 2003
A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
K032757 · EIA
A-Dec, Inc.
Dental · 96d
Cleared Dec 10, 2003
SCORPIO LOW PROFILE TIBIAL TRAY
K032829 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 10, 2003
MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR
K032841 · DPT
Moor Instruments, Ltd.
Cardiovascular · 90d
Cleared Dec 10, 2003
STRYKER SPINE MAPS SYSTEM
K032855 · MNH
Howmedica Osteonics
Orthopedic · 89d
Cleared Dec 10, 2003
EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT
K032953 · KLE
Pulpdent Corporation
Dental · 79d
Cleared Dec 10, 2003
TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700
K033025 · DXN
Tytan Medical Corp.
Cardiovascular · 75d
Cleared Dec 10, 2003
C-GRAFT
K033110 · LYC
The Clinician'S Preference, LLC
Dental · 71d
Cleared Dec 10, 2003
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269 · OCW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 62d
Cleared Dec 10, 2003
IMMEDIATE STABILIZING IMPLANT (ISI)
K033392 · DZE
"O" Co., Inc.
Dental · 48d
Cleared Dec 10, 2003
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006,...
K033537 · FGE
Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Dec 10, 2003
ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
K033544 · IPF
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 30d
Cleared Dec 10, 2003
MODIFICATION TO AURORA DS
K033586 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 27d
Cleared Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · HRS
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Dec 09, 2003
REDLINE ANTHRAX ALERT TEST
K030370 · NPO
Tetracore, Inc.
Microbiology · 308d
Cleared Dec 09, 2003
CD LEYCOM PRESSURE/VOLUME CATHETERS
K031599 · DQO
Cd Leycom BV
Cardiovascular · 202d
Cleared Dec 09, 2003
SPIROTEL, MODEL 29-1020
K031643 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 196d
Cleared Dec 09, 2003
MONA LISA ASPIRATION NEEDLE
K032208 · MQE
Fertility Technology Resources, Inc.
Obstetrics & Gynecology · 144d
Cleared Dec 09, 2003
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K032690 · LFL
Misonix, Inc.
General & Plastic Surgery · 98d