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
35425–35448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2015
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
K141687 · JXG
Aesculap, Inc.
Neurology · 294d
Cleared Apr 02, 2015
MYGAIT STIMULATION SYSTEM
K141812 · GZI
Otto Bock Healthcare Products GmbH
Neurology · 269d
Cleared Apr 02, 2015
FLASHPAK STERILIZATION CONTAINER SYSTEM
K141826 · FRG
Symmetry Medical Inc- Manchester
General Hospital · 269d
Cleared Apr 02, 2015
PHYSICA KR KNEE SYSTEM
K141934 · JWH
Lima Corporate S.P.A.
Orthopedic · 259d
Cleared Apr 02, 2015
BRIGHTMATTER NAVIGATION SYSTEM
K142024 · HAW
Synaptive Medical, Inc.
Neurology · 251d
Cleared Apr 02, 2015
Reliance Interspinous Plate System
K142217 · PEK
Reliance Medical Systems, LLC
Orthopedic · 233d
Cleared Apr 02, 2015
Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
K143018 · PIF
Covidien
Gastroenterology & Urology · 164d
Cleared Apr 02, 2015
Tanning Lamp
K143043 · LEJ
Unilam Co., Ltd.
General & Plastic Surgery · 162d
Cleared Apr 02, 2015
IS4000 8mm Harmonic ACE Curved Shears
K143132 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 153d
Cleared Apr 02, 2015
Hahn Tapered Implant System
K143353 · DZE
Prismatik Dentalcraft, Inc.
Dental · 129d
Cleared Apr 02, 2015
AWARE
K143372 · MWI
Ambient Clinical Analytics
Cardiovascular · 128d
Cleared Apr 02, 2015
Euphora Rapid Exchange Balloon Dilatation Catheter
K143480 · LOX
Medtronic, Inc.
Cardiovascular · 115d
Cleared Apr 02, 2015
Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
K150010 · PIO
Cedic S.R.L.
Gastroenterology & Urology · 90d
Cleared Apr 02, 2015
J2A Dental Implant System, J2C Dental Implant System
K150060 · DZE
Kj Meditech Co., Ltd.
Dental · 79d
Cleared Apr 02, 2015
GC85A
K150165 · KPR
Samsung Electronics Co., Ltd.
Radiology · 66d
Cleared Apr 02, 2015
Disposable Blood Pressure Cuff Guard
K150227 · DXQ
Pinhu Sama Medical Packing Co., Ltd.
Cardiovascular · 59d
Cleared Apr 02, 2015
QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve...
K150413 · IPF
Cymedica Orthopedics, Inc.
Physical Medicine · 43d
Cleared Apr 02, 2015
Force Fiber OrthoTape suture
K150438 · GAT
Teleflexmedical, Inc.
General & Plastic Surgery · 42d
Cleared Apr 02, 2015
Total Bilirubin
K150510 · CIG
Abbott Laboratories
Chemistry · 34d
Cleared Apr 02, 2015
Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307,...
K150545 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 30d
Cleared Apr 02, 2015
EzDent-i /E2/Prora View
K150747 · LLZ
LK Consulting Group USA, Inc.
Radiology · 10d
Cleared Apr 01, 2015
CRIT-LINE IV SYSTEM
K141997 · KOC
Fresenius Medical Care
Gastroenterology & Urology · 252d
Cleared Apr 01, 2015
125mL CT Syringe
K142745 · DXT
Coeur, Inc.
Cardiovascular · 189d
Cleared Apr 01, 2015
Sensititre Susceptibility plates
K143288 · JWY
Thermo Fisher Scientific
Microbiology · 135d