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
66289–66312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
K042506 · DXN
Omron Healthcare, Inc.
Cardiovascular · 202d
Cleared Apr 05, 2005
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
K043503 · HJO
Visx, Incorporated
Ophthalmic · 106d
Cleared Apr 05, 2005
RELIEVA SINUS BALLOON DILATION CATHETER
K043527 · LRC
Exploramed Nc1, Inc.
Ear, Nose, Throat · 105d
Cleared Apr 05, 2005
INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
K050131 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 74d
Cleared Apr 05, 2005
ICC INSULIN SAFEPRO SAFETY SYRINGE
K050134 · MEG
Formosa Medical Devices, Inc.
General Hospital · 74d
Cleared Apr 05, 2005
HL 200 ELECTRONIC STETHOSCOPE
K050169 · DQD
Health & Life Co., Ltd.
Cardiovascular · 69d
Cleared Apr 05, 2005
DEPOTONE
K050505 · FMI
Imprint Pharmaceuticals Limited
General Hospital · 36d
Cleared Apr 05, 2005
BONE BLOCK FIXATION SET
K050515 · DZL
Straumann USA, Inc.
Dental · 35d
Cleared Apr 05, 2005
HEALTH BUDDY APPLIANCE
K050567 · DRG
Health Hero Network, Inc.
Cardiovascular · 32d
Cleared Apr 05, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM
K050587 · DXN
Health & Life Co., Ltd.
Cardiovascular · 28d
Cleared Apr 05, 2005
MUSE CARDIOLOGY INFORMATION SYSTEM
K050614 · DQK
Ge Medical Systems Information...
Cardiovascular · 26d
Cleared Apr 05, 2005
SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
K050648 · HQC
Advanced Medical Optics, Inc.
Ophthalmic · 22d
Cleared Apr 05, 2005
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00
K050742 · MHX
Philips Medical Systems
Cardiovascular · 14d
Cleared Apr 04, 2005
CIDEX OPA CONCENTRATE
K032959 · MED
Advanced Sterilization Products
General Hospital · 559d
Cleared Apr 04, 2005
MICROLUX DL
K041614 · EAZ
Addent, Inc.
Dental · 293d
Cleared Apr 04, 2005
AIDA WITH DICOM AND HL7 INTERFACE
K043324 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 123d
Cleared Apr 04, 2005
SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES
K050450 · LYZ
Zibo Blue Intco Plastic & Rubber...
General Hospital · 41d
Cleared Apr 01, 2005
SURGICAL DESIGN CIRCUMCISION CLAMP
K043533 · HFX
Surgical Design, Inc.
Obstetrics & Gynecology · 100d
Cleared Apr 01, 2005
BLOOD HAND PUMP ADMINISTRATION SET
K050115 · BRZ
Cardinal Health, Alaris Products
General Hospital · 73d
Cleared Apr 01, 2005
QMS VANCOMYCIN
K050419 · LEH
Seradyn, Inc.
Toxicology · 42d
Cleared Apr 01, 2005
TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
K050488 · FAS
Prosurg, Inc.
Gastroenterology & Urology · 35d
Cleared Apr 01, 2005
ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
K050510 · IYN
Shimadzu Medical Systems
Radiology · 31d
Cleared Apr 01, 2005
MDA B.30
K050513 · JPA
bioMerieux, Inc.
Hematology · 31d
Cleared Apr 01, 2005
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
K050548 · GAW
Surgical Specialties Corp
General & Plastic Surgery · 30d