Search FDA 510(k) Database

Cleared Oct 10, 2018

SBG Black Nitrile Powder Free Medical Examination Glove

K180468 · LZA

Showa Best Glove, Inc.

General Hospital · 231d

Cleared Oct 10, 2018

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7...

K181038 · PSQ

Cormatrix Cardiovascular, Inc.

Cardiovascular · 174d

Cleared Oct 10, 2018

Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures

K181774 · GAT

Teleflex Medical Incorporated

General & Plastic Surgery · 99d

Cleared Oct 10, 2018

Elvie Pump

K181863 · HGX

Chiaro Technology Limited

Obstetrics & Gynecology · 90d

Cleared Oct 10, 2018

BioHorizons Tapered IM Implants

K182070 · DZE

BioHorizons Implant Systems, Inc.

Dental · 70d

Cleared Oct 10, 2018

Sterile High-pressure Angiographic Syringes for Single-use

K182289 · DXT

Shenzhen Baoan Medical Supplies Co.,...

Cardiovascular · 48d

Cleared Oct 10, 2018

Geminus Volar Distal Radius Plate System

K182492 · HRS

Skeletal Dynamics, LLC

Orthopedic · 29d

Cleared Oct 10, 2018

ClotTriever Thrombectomy System

K182531 · QEW

Inari Medical

Cardiovascular · 26d

Cleared Oct 09, 2018

Senhance Surgical System

K181517 · NAY

Transenterix, Inc.

General & Plastic Surgery · 123d

Cleared Oct 09, 2018

Scarlet AL-T

K181818 · OVD

Spineart

Orthopedic · 92d

Cleared Oct 09, 2018

Ziostation2

K181892 · LLZ

Ziosoft, Inc.

Radiology · 88d

Cleared Oct 09, 2018

Swiss LithoClast Trilogy

K182490 · FEO

E.M.S Electro Medical Systems S.A

Gastroenterology & Urology · 28d

Cleared Oct 06, 2018

Bluetooth blood pressure monitor

K182018 · DXN

Shenzhen Kingyield Technology Co., Ltd.

Cardiovascular · 71d

Cleared Oct 06, 2018

Vinyl Patient Examination Gloves

K182117 · LYZ

Jiangxi Zhonghong Pulin Medical...

General Hospital · 61d

Cleared Oct 05, 2018

Straumann SC Variobase Abutments

K173945 · NHA

Institut Straumann AG

Dental · 283d

Cleared Oct 05, 2018

Royal Flush Plus High-Flow Catheter

K180054 · DQO

Cook Incorporated

Cardiovascular · 270d

Cleared Oct 05, 2018

GORE Tri-Lumen Catheter

K180919 · DQY

W. L. Gore and Associates, Inc.

Cardiovascular · 179d

Cleared Oct 05, 2018

MAGNETOM Sola

K181322 · LNH

Siemens Medical Solutions USA, Inc.

Radiology · 140d

Cleared Oct 05, 2018

SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices

K181531 · MAX

Spineex, Inc.

Orthopedic · 116d

Cleared Oct 05, 2018

ORTHOLOC SPS Shoulder Plating System

K181587 · HRS

Tornier, Inc.

Orthopedic · 112d

Cleared Oct 05, 2018

EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT...

K181603 · NKG

K2m, Inc.

Orthopedic · 108d

Cleared Oct 05, 2018

B-Laser Atherectomy System

K181642 · MCW

Eximo Medical, Ltd.

Cardiovascular · 106d

Cleared Oct 05, 2018

Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model...

K181725 · PQK

Avenu Medical, Inc.

Cardiovascular · 98d

Cleared Oct 05, 2018

NuVasive Cohere Thoracolumbar Interbody System

K181860 · MAX

Nu Vasive, Incorporated

Orthopedic · 85d