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

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175,820 results
35353–35376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2015
FortiBridge Anterior Cervical Plate System
K143706 · KWQ
Nanovis Spine, LLC
Orthopedic · 102d
Cleared Apr 10, 2015
DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems
K150204 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 71d
Cleared Apr 10, 2015
PROFEMUR Preserve Classic Stem
K150302 · LZO
Microport Orthopedics, Inc.
Orthopedic · 63d
Cleared Apr 10, 2015
AlfaSight 9000 Thermographic System
K150457 · LHQ
Alfa Thermodiagnostics, Inc.
Radiology · 49d
Cleared Apr 10, 2015
MDNG-3220 (Nio 3MP LED)
K150821 · PGY
Barco
Radiology · 14d
Cleared Apr 09, 2015
KOGENT SPETZLER LIGHTED SUCTION TUBES
K141781 · HBI
Katalyst Surgical, LLC
General & Plastic Surgery · 281d
Cleared Apr 09, 2015
LIOLI IOL DELIVERY SYSTEM
K142056 · MSS
Ast Products, Inc.
Ophthalmic · 254d
Cleared Apr 09, 2015
Kobold Ring and Tandem Applicator Set
K142330 · JAQ
Kobold, LLC
Radiology · 232d
Cleared Apr 09, 2015
G-scan Brio
K142421 · LNH
Esaote, S.P.A.
Radiology · 224d
Cleared Apr 09, 2015
APTUS Foot System
K142581 · HRS
Medartis AG
Orthopedic · 206d
Cleared Apr 09, 2015
Vantage Titan 3T
K143008 · LNH
Toshibamedical Systems Corporation
Radiology · 171d
Cleared Apr 09, 2015
O-MAR
K143253 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 147d
Cleared Apr 09, 2015
Prelude SNAP Splittable Sheath Introducer
K143255 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 147d
Cleared Apr 09, 2015
PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)
K143258 · MAX
4Web, Inc.
Orthopedic · 147d
Cleared Apr 09, 2015
NeoMed NeoConnect Enteral Syringes with ENFit Connector
K143344 · PNR
Neomed, Inc.
Gastroenterology & Urology · 139d
Cleared Apr 09, 2015
MASTERmatic LUX
K143465 · EFA
Kaltenbach & Voigt GmbH
Dental · 126d
Cleared Apr 09, 2015
BD INTIMA II CLOSED IV CATHETER
K143610 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 111d
Cleared Apr 09, 2015
Equinoxe Mega Prosthesis
K143659 · KWT
Exactech, Inc.
Orthopedic · 107d
Cleared Apr 09, 2015
Arthrex Blunt Tip Screws with Fiber Tape
K143702 · HTY
Arthrex, Inc.
Orthopedic · 106d
Cleared Apr 09, 2015
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
K143723 · GEX
Fotona D.D.
General & Plastic Surgery · 101d
Cleared Apr 09, 2015
LightStim Professional 2-Panel Light
K150098 · OHS
Led Intellectual Properties, LLC
General & Plastic Surgery · 79d
Cleared Apr 09, 2015
ApexM
K150183 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 72d
Cleared Apr 09, 2015
Chocolate PTCA Balloon Catheter
K150292 · LOX
Trireme Medical, LLC
Cardiovascular · 62d
Cleared Apr 09, 2015
18ch T/R Knee Coil
K150331 · MOS
Quality Electrodynamics, LLC
Radiology · 58d