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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
52537–52560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2009
REVERE 6.35 STABILIZATION SYSTEM
K091782 · NKB
Globus Medical, Inc.
Orthopedic · 57d
Cleared Aug 13, 2009
TRUSS THORACOLUMBAR PLATE SYSTEM
K092108 · KWQ
Globus Medical, Inc.
Orthopedic · 30d
Cleared Aug 12, 2009
INVISION SYSTEM
K083728 · IYO
Inneroptic Technology, Inc.
Radiology · 239d
Cleared Aug 12, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090551 · LYZ
Tangshan Zhongpu Plastic Products...
General Hospital · 163d
Cleared Aug 12, 2009
FOOTPRINT URINARY DRAINAGE CATHETER
K090576 · EZD
Footprint Medical
Gastroenterology & Urology · 162d
Cleared Aug 12, 2009
TANSCU O2
K090681 · KPJ
Electrochemical Oxygen Concepts, Inc.
General & Plastic Surgery · 149d
Cleared Aug 12, 2009
HDR PROSTATE TEMPLATE AND ACCESSORIES
K091230 · JAQ
Photon Technologies Corporation
Radiology · 107d
Cleared Aug 12, 2009
NIPRO DISPOSABLE SYRINGE
K091279 · FMF
Nipro Medical Corporation
General Hospital · 103d
Cleared Aug 12, 2009
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
K091453 · KRO
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Aug 12, 2009
SWITCH TRT
K091552 · KLW
Audifon GmbH & Co. KG
Ear, Nose, Throat · 77d
Cleared Aug 12, 2009
AIXPLORER ULTRASOUND SYSTEM
K091970 · IYN
Supersonic Imagine
Radiology · 42d
Cleared Aug 12, 2009
OMNISURE URETHRAL SLING, MODEL OTK52
K092203 · OTN
Mpathy Medical Devices, Ltd.
Gastroenterology & Urology · 21d
Cleared Aug 12, 2009
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
K092223 · PSZ
Binax, Inc.
Microbiology · 20d
Cleared Aug 12, 2009
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
K092315 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 13d
Cleared Aug 11, 2009
JIAJIAN ACUPUNCTURE NEEDLE
K090199 · MQX
Wuxi Jiajian Medical Instrument Co.,...
General Hospital · 196d
Cleared Aug 11, 2009
POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300,...
K090342 · JXG
Sophysa SA
Neurology · 182d
Cleared Aug 11, 2009
SENTINEL SPINAL SYSTEM
K090343 · KWP
Life Spine
Orthopedic · 182d
Cleared Aug 11, 2009
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
K091410 · IKT
Spes Medica Srl
Neurology · 90d
Cleared Aug 11, 2009
PROTEUS 235 PROTON THERAPY SYSTEM
K091629 · LHN
Ion Beam Applications S.A.
Radiology · 69d
Cleared Aug 11, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K092238 · MQB
Agfa Healthcare N.V.
Radiology · 19d
Cleared Aug 10, 2009
SONIC AIR MM1500 + (MID), MODEL 50400014
K081268 · ELC
Micro-Mega Societe Anonyme
Dental · 462d
Cleared Aug 10, 2009
GDX VCC WITH ECC SOFTWARE
K082016 · MYC
Carl Zeiss Meditec, Inc.
Ophthalmic · 391d
Cleared Aug 10, 2009
ZOOM-100DC
K082886 · OLT
Brainscope Company, Inc.
Neurology · 314d
Cleared Aug 10, 2009
MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP
K090662 · DQA
Masimo Corporation
Anesthesiology · 151d