Search FDA 510(k) Database

Cleared May 10, 2019

GenePOC Carba

K190275 · PMY

Genepoc, Inc.

Microbiology · 91d

Cleared May 10, 2019

Therm-X

K190854 · IRP

Zenith Technical Innovations

Physical Medicine · 38d

Cleared May 10, 2019

6400 Ultrasound System (MyLabX6, MyLabX7)

K190989 · IYN

Esaote, S.P.A.

Radiology · 25d

Cleared May 10, 2019

ExactVu High Resolution Micro-Ultrasound System

K190995 · IYN

Exact Imaging, Inc.

Radiology · 24d

Cleared May 10, 2019

L10 LED Light Source with AIM, L11 LED Light Source with AIM

K191046 · OWN

Stryker

General & Plastic Surgery · 21d

Cleared May 09, 2019

Delta Dual Mobility System

K181491 · LZO

Lima Corporate S.P.A.

Orthopedic · 337d

Cleared May 09, 2019

TOF-Cuff monitor

K181894 · DXN

Rgb Medical Devices SA

Anesthesiology · 297d

Cleared May 09, 2019

DePuy Synthes Sterilization Container System

K181933 · KCT

Synthes (Usa) Products, LLC / Depuy...

General Hospital · 294d

Cleared May 09, 2019

ATEC IOM Accessory Instruments

K182617 · PDQ

Alphatec Spine, Inc.

Neurology · 227d

Cleared May 09, 2019

TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge

K183160 · JPA

Haemonetics Corporation

Hematology · 175d

Cleared May 09, 2019

Encore System

K183310 · ORY

Siesta Medical, Inc.

Dental · 161d

Cleared May 09, 2019

Unscented Menstrual Tampon

K190218 · HEB

Qingdao Youjia Hygiene Technology...

Obstetrics & Gynecology · 94d

Cleared May 09, 2019

Wingman 14C Crossing Catheter

K190393 · DQY

Reflow Medical, Inc.

Cardiovascular · 79d

Cleared May 09, 2019

CYGNUS™ Anterior Cervical Plate System

K190666 · KWQ

MiRus, LLC

Orthopedic · 55d

Cleared May 09, 2019

Rowheels Revolution 1.0

K190699 · IOR

Rowheels, Inc.

Physical Medicine · 52d

Cleared May 09, 2019

V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature...

K190917 · MLR

STERIS Corporation

General Hospital · 30d

Cleared May 09, 2019

Magic Clear Aligners

K190948 · NXC

Voodoo Manufacturing, Inc.

Dental · 28d

Cleared May 08, 2019

Reprocessed ViewFlex Xtra ICE Catheter

K182238 · OWQ

Stryker Sustainability Solutions

Cardiovascular · 261d

Cleared May 08, 2019

GlucoLeader Enhance Blood Glucose Monitoring System

K182428 · NBW

Hmd Biomedical, Inc.

Chemistry · 244d

Cleared May 08, 2019

Electrosurgical accessory

K183126 · GEI

New Deantronics Taiwan , Ltd.

General & Plastic Surgery · 176d

Cleared May 08, 2019

SomnoDent Avant

K183443 · LRK

Somnomed, Inc.

Dental · 147d

Cleared May 08, 2019

Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic...

K183461 · GBM

Teleflexmedical, Inc.

Gastroenterology & Urology · 145d

Cleared May 08, 2019

UNiD Patient specific 3D printed TLIF cage

K190092 · MAX

Medicrea International SA

Orthopedic · 110d

Cleared May 08, 2019

COLOSSEUM Mesh

K190147 · MQP

Globus Medical, Inc.

Orthopedic · 99d