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
73465–73488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2003
SYNTRA + DIALYZER, MODEL 200
K023664 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 113d
Cleared Feb 21, 2003
COAXIA FLOCONTROL CATHETER
K023914 · MJN
Coaxia, Inc.
Cardiovascular · 88d
Cleared Feb 21, 2003
AUTOCON II 200 ELECTROSURGICAL GENERATOR
K023924 · GEI
Karl Storz Endoscopy
General & Plastic Surgery · 88d
Cleared Feb 21, 2003
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K023929 · MOS
Advanced Imaging Research, Inc.
Radiology · 88d
Cleared Feb 21, 2003
JEROME GLASS RING
K023959 · HAX
The Jerome Group, Inc.
Neurology · 86d
Cleared Feb 21, 2003
LEO III TX/RX QUADRATURE KNEE COIL
K023982 · MOS
Usa Instruments, Inc.
Radiology · 81d
Cleared Feb 21, 2003
SABER TECH IMPLANTS SYSTEM
K024044 · DZE
Imtec Corp.
Dental · 77d
Cleared Feb 21, 2003
MERIT MEDICAL 1-ML SYRINGE
K024052 · FMF
Merit Medical Systems, Inc.
General Hospital · 77d
Cleared Feb 21, 2003
PRIMELUNG
K024149 · JAK
Accuimage Diagnostics Corp.
Radiology · 67d
Cleared Feb 21, 2003
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT...
K024193 · MMI
Ortho-Clinical Diagnostics
Chemistry · 63d
Cleared Feb 21, 2003
TERUMO SURGUARD SAFETY SYRINGE
K024249 · MEG
Terumo Medical Corp.
General Hospital · 60d
Cleared Feb 21, 2003
THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
K024309 · BYI
Advanced Respiratory
Anesthesiology · 59d
Cleared Feb 21, 2003
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
K030045 · DIH
Olympus America, Inc.
Chemistry · 46d
Cleared Feb 21, 2003
CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES
K030190 · MQX
Suzhou Sen Sen Medical Supplies , Ltd.
General Hospital · 31d
Cleared Feb 21, 2003
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K030240 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 29d
Cleared Feb 21, 2003
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K030241 · KWP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)
K030252 · KWP
Ortho Tec, LLC
Orthopedic · 28d
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K030253 · KWP
Ortho Tec, LLC
Orthopedic · 28d
Cleared Feb 21, 2003
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
K030286 · NBC
Biosite Incorporated
Chemistry · 24d
Cleared Feb 21, 2003
JASUN, MODELS DT-01F AND DT-11F
K030361 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 18d
Cleared Feb 20, 2003
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
K020595 · JWZ
Xenotope Diagnostics, Inc.
Microbiology · 363d
Cleared Feb 20, 2003
MEDLITE Q-SWITHCED LASER
K022709 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 190d
Cleared Feb 20, 2003
MAGIC INFUSION CATHETER
K023351 · KRA
Advanced Interventional Technologies,...
Cardiovascular · 136d
Cleared Feb 20, 2003
ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
K023630 · GCJ
Guidant Corporation, Cardiac Surgery
General & Plastic Surgery · 115d