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
31681–31704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 2016
AcceleDent Aura
K153048 · OYH
Orthoaccel Technologies, Inc.
Dental · 263d
Cleared Jul 08, 2016
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
K153137 · LCO
Instrumentation Laboratory CO
Hematology · 252d
Cleared Jul 08, 2016
i-STAT Alinity System with i-STAT Sodium test
K153357 · JGS
Abbott Point of Care, Inc.
Chemistry · 231d
Cleared Jul 08, 2016
Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
K153700 · OLO
Aesculap Implant Systems, LLC
Orthopedic · 198d
Cleared Jul 08, 2016
AccuLIF TL and PL Cage
K160715 · MAX
Stryker Corporation
Orthopedic · 115d
Cleared CT Jul 08, 2016
ULTRASHAPE POWER SYSTEM
K160896 · OHV
Syneron Medical, Ltd.
General & Plastic Surgery · 99d
Cleared Jul 08, 2016
LITe BIO Delivery System
K160978 · FMF
Stryker Corporation
General Hospital · 92d
Cleared Jul 08, 2016
sensiLight Mini
K161089 · OHT
El Global Trade, Ltd.
General & Plastic Surgery · 81d
Cleared Jul 08, 2016
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
K161192 · LZO
Zimmer GmbH
Orthopedic · 72d
Cleared Jul 08, 2016
S-scan
K161238 · LNH
Esaote, S.P.A.
Radiology · 67d
Cleared Jul 08, 2016
TightRail Sub-C Rotating Dilator Sheath
K161333 · DRE
Spectranetics, Inc.
Cardiovascular · 57d
Cleared Jul 07, 2016
Gemini Sterilization Wrap
K152564 · FRG
Medline Industries, Inc.
General Hospital · 302d
Cleared Jul 07, 2016
AirLife Adult Heated Wire Circuit
K153234 · BZE
Carefusion, Inc.
Anesthesiology · 241d
Cleared Jul 07, 2016
Styrker OrthoMap Express Knee System
K153240 · OLO
Stryker Corporate
Orthopedic · 241d
Cleared Jul 07, 2016
Cydar EV
K160088 · OWB
Cydar , Ltd.
Radiology · 174d
Cleared Jul 07, 2016
CorticaLINK Spinal Fusion Platform
K160722 · NKB
Facetlink Dba Linkspine
Orthopedic · 113d
Cleared Jul 07, 2016
Habib EUS RFA
K161305 · GEI
Emcision , Ltd.
General & Plastic Surgery · 58d
Cleared Jul 06, 2016
Voyant Fine Fusion
K153017 · GEI
Applied Medical Resources
General & Plastic Surgery · 265d
Cleared Jul 06, 2016
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets,...
K153074 · LZH
Covidien
General Hospital · 258d
Cleared Jul 06, 2016
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
K153231 · EMA
GC America, Inc.
Dental · 240d
Cleared Jul 06, 2016
V-PRO® 1 Plus and V-PRO® maX Low Temperature
K160433 · MLR
STERIS Corporation
General Hospital · 141d
Cleared Jul 06, 2016
SunTech CT40 Spot-check Vital Signs Device
K160439 · DXN
Suntech Medical
Cardiovascular · 140d
Cleared Jul 06, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160557 · DXN
Health & Life Co., Ltd.
Cardiovascular · 128d
Cleared CT Jul 06, 2016
NeuGuide
K160569 · PBQ
Pop Medical Solutions
Obstetrics & Gynecology · 128d