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
56641–56664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2008
SPINAL USA INTERBODY FUSION DEVICE
K080314 · MAX
Spinal USA
Orthopedic · 97d
Cleared May 13, 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D
K080337 · DXN
Microlife Corp.
Cardiovascular · 95d
Cleared May 13, 2008
CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR
K080385 · ITI
E1 Ent., Inc.
Physical Medicine · 90d
Cleared May 13, 2008
ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
K080400 · MSD
AngioDynamics, Inc.
Gastroenterology & Urology · 90d
Cleared May 13, 2008
PROGENIX DBM PUTTY
K080462 · NUN
Medtronic Sofamor Danek
Dental · 83d
Cleared May 13, 2008
DURAFINISH ALL-CURE, MODEL S296
K080549 · EBD
Parkell, Inc.
Dental · 76d
Cleared May 13, 2008
CORRIDOR4DM
K080575 · KPS
Invia
Radiology · 74d
Cleared May 13, 2008
IV ADMINISTRATION SET
K080660 · FPA
U.S. Safety Syringes Co., Inc.
General Hospital · 64d
Cleared May 13, 2008
NOVOLET
K080665 · FPA
U.S. Safety Syringes Co., Inc.
General Hospital · 64d
Cleared May 13, 2008
DENTRON SENSOR
K080738 · EAP
Dentron Systems, LLC
Radiology · 57d
Cleared May 13, 2008
MODIFICATION TO AESKULISA DS DNA G
K081251 · LSW
Aesku Diagnostics
Immunology · 11d
Cleared May 12, 2008
TUTODENT DENTAL MEMBRANE
K073097 · NPL
Tutogen Medical U.S., Inc.
Dental · 193d
Cleared May 12, 2008
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87...
K080238 · DQA
Masimo Corporation
Anesthesiology · 102d
Cleared May 12, 2008
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
K080607 · JIX
Roche Diagnostics Corp.
Chemistry · 69d
Cleared May 12, 2008
BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR
K080750 · JOJ
STERIS Corporation
General Hospital · 56d
Cleared May 12, 2008
THERMOFLASH LX-26
K080759 · FLL
Jxb Co. Ltd Guangzhou (China)
General Hospital · 55d
Cleared May 12, 2008
REVOLUTION 45MHZ IVUS IMAGING CATHETER
K080891 · OBJ
Volcano Corporation
Cardiovascular · 42d
Cleared May 12, 2008
CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS
K080936 · JWH
Conformis, Inc.
Orthopedic · 40d
Cleared May 12, 2008
DORIPENEM 10UG BBL SENSI-DISC
K080998 · JTN
Becton, Dickinson & CO
Microbiology · 35d
Cleared May 12, 2008
CAPSURE PS (R) SPINE SYSTEM
K081228 · MNI
Spine Wave, Inc.
Orthopedic · 12d
Cleared May 09, 2008
ALCON VISION SYSTEM
K063583 · HQC
Alcon
Ophthalmic · 526d
Cleared May 09, 2008
KSEA CLEARVISION II, MODEL 40334120
K072410 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 256d
Cleared May 09, 2008
OMNI-TIGHT
K072595 · DZE
Basic Dental Implant Systems, Inc.
Dental · 238d
Cleared May 09, 2008
AXXENT VAGINAL APPLICATOR
K072616 · JAD
Xoft, Inc.
Radiology · 235d