Search FDA 510(k) Database

Cleared Dec 10, 2018

CATSmart

K180831 · CAC

Fresenius Kabi AG

Cardiovascular · 255d

Cleared Dec 10, 2018

LUTRONIC GENIUS Radiofrequency System

K180945 · GEI

Lutronic Corporation

General & Plastic Surgery · 243d

Cleared Dec 10, 2018

Hailie Sensor

K181405 · CAF

Adherium (Nz), Ltd.

Anesthesiology · 195d

Cleared Dec 10, 2018

X-ray Imaging System for the McLaren Proton Treatment System

K181498 · LHN

Ehmetdx, LLC

Radiology · 186d

Cleared Dec 10, 2018

FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System

K181675 · PTC

Taidoc Technology Corporation

Chemistry · 168d

Cleared Dec 10, 2018

VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance

K181766 · LON

bioMerieux, Inc.

Microbiology · 160d

Cleared Dec 10, 2018

Glenoid Polyaxial Non-locking Screws

K181826 · PHX

Medacta International S.A.

Orthopedic · 154d

Cleared Dec 10, 2018

Disposable Temperature Probe

K181967 · FLL

Shenzhen Launch Electrical Co., Ltd.

General Hospital · 140d

Cleared Dec 10, 2018

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer

K182038 · JFY

Yd Diagnostics Corporation

Chemistry · 133d

Cleared Dec 10, 2018

BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision...

K182075 · MHX

Shenzhen Mindray Bio-Medical...

Cardiovascular · 131d

Cleared Dec 10, 2018

ARK Tramadol Assay

K182280 · DJG

ARK Diagnostics, Inc.

Toxicology · 110d

Cleared Dec 10, 2018

Applanation tonometer AT-2

K182491 · HKY

Takagi Seiko Co., Ltd.

Ophthalmic · 90d

Cleared Dec 10, 2018

LipiScan Dynamic Meibomian Imager

K182506 · HKI

Tearscience, Inc.

Ophthalmic · 89d

Cleared Dec 10, 2018

Route 92 Medical Delivery Catheter

K182512 · DQY

Route 92 Medical, Inc.

Neurology · 89d

Cleared Dec 10, 2018

Lucent® XP

K182584 · MAX

Spinal Elements, Inc.

Orthopedic · 81d

Cleared Dec 10, 2018

CelerityTM 10 STEAM Chemical Indicator

K182724 · JOJ

STERIS Corporation

General Hospital · 73d

Cleared Dec 10, 2018

Distal Radius Plating System

K182810 · HRS

Miami Device Solutions, LLC

Orthopedic · 68d

Cleared Dec 10, 2018

SabreLine and SabreGuard Laser Fibers

K182831 · GEX

Coloplast Corp.

General & Plastic Surgery · 62d

Cleared Dec 10, 2018

Mega Plus Spine System

K183080 · NKB

Bk Meditech, Co., Ltd.

Orthopedic · 35d

Cleared Dec 07, 2018

Neck Care Therapy, Model: SYK 509B

K172897 · NUH

Shenzhen Osto Technology Co., Ltd.

Neurology · 441d

Cleared Dec 07, 2018

SignalMark Lung Biopsy Site Marker

K180175 · GDW

View Point Medical, Inc.

General & Plastic Surgery · 319d

Cleared Dec 07, 2018

Resin for Temporary Crown & Bridge

K180657 · EBG

Dentis Co., Ltd.

Dental · 269d

Cleared Dec 07, 2018

ICONN Campbell Interference Screw

K180670 · HWC

Iconn Orthopedics, LLC

Orthopedic · 268d

Cleared Dec 07, 2018

CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid),...

K180679 · KPO

Global Scientific Technologies, LLC

Gastroenterology & Urology · 267d