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
80617–80640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2001
VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL...
K003893 · HRX
Oratec Interventions, Inc.
Orthopedic · 73d
Cleared Mar 01, 2001
ENA EIA KIT RANGE
K010146 · LLL
The Binding Site, Ltd.
Immunology · 43d
Cleared Mar 01, 2001
ENA EIA KIT
K010147 · LLL
The Binding Site, Ltd.
Immunology · 43d
Cleared Mar 01, 2001
BD ECLIPSE HYPODERMIC NEEDLE
K010188 · FMI
Bd Medical Systems
General Hospital · 38d
Cleared Mar 01, 2001
CONTOUR PROFILE LASER
K010285 · GEX
Sciton, Inc
General & Plastic Surgery · 29d
Cleared Mar 01, 2001
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K010320 · LYC
Depuyacromed
Dental · 27d
Cleared Mar 01, 2001
LOGIQ 500
K010329 · IYN
General Electric Co.
Radiology · 27d
Cleared Mar 01, 2001
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
K010382 · CCL
Sensidyne, Inc.
Anesthesiology · 21d
Cleared Mar 01, 2001
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
K010511 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 8d
Cleared Feb 28, 2001
MAC ACUPUNCTURE NEEDLE
K002827 · MQX
Haenglim Seowon Corp.
General Hospital · 170d
Cleared Feb 28, 2001
VASCULAR ARCHITECTS PERISCOPE DEVICE
K003719 · DWX
Vascular Architects, Inc.
Cardiovascular · 86d
Cleared Feb 28, 2001
ALI 3D TOOL MODULE FOR MEDICAL IMAGES
K003762 · LLZ
A.L.I. Technologies, Inc.
Radiology · 84d
Cleared Feb 28, 2001
ANATOMICAL PRESS-FIT HUMERAL STEM
K003801 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 82d
Cleared Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
K003865 · DKZ
Roche Diagnostics Corp.
Toxicology · 77d
Cleared Feb 28, 2001
DIMENSION PSA FLEX REAGENT CARTRIDGE
K003963 · LTJ
Dade Behring, Inc.
Immunology · 68d
Cleared Feb 28, 2001
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
K010077 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 49d
Cleared Feb 28, 2001
FLUOROPERM 151-OK, PARAGON HDS 100-OK
K010109 · MUW
Paragon Vision Sciences
Ophthalmic · 47d
Cleared Feb 28, 2001
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
K010111 · JJY
Medical Analysis Systems, Inc.
Chemistry · 47d
Cleared Feb 28, 2001
TETRIC CERAM HB
K010250 · EBF
Ivoclar North America, Inc.
Dental · 33d
Cleared Feb 28, 2001
ZOLL M SERIES
K010257 · MKJ
Zoll Medical Corp
Cardiovascular · 30d
Cleared Feb 28, 2001
CARDIOMEDICS ECP SYSTEM
K010261 · DRN
Cardiomedics, Inc.
Cardiovascular · 30d
Cleared Feb 28, 2001
DUAL LUMEN MIDLINE CATHETER
K010349 · LJS
Catheter Innovations, Inc.
General Hospital · 23d
Cleared Feb 28, 2001
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP,...
K010444 · GEI
C.R. Bard, Inc.
General & Plastic Surgery · 14d
Cleared Feb 27, 2001
OLYMPUS ENDOSCOPIC LIGATION DEVICE
K001744 · MND
Olympus America, Inc.
Gastroenterology & Urology · 264d