Search FDA 510(k) Database

Cleared Nov 28, 2018

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite

K181604 · ELW

Hrs Co., Ltd.

Dental · 162d

Cleared Nov 28, 2018

SMS Femoral Stem

K181693 · LZO

Medacta International S.A.

Orthopedic · 154d

Cleared Nov 28, 2018

AEON Endoscopic Stapler

K182380 · GDW

Lexington Medical, Inc.

General & Plastic Surgery · 89d

Cleared Nov 28, 2018

BGM014 Blood Glucose Monitoring System

K182992 · NBW

Apex BioTechnology Corp.

Chemistry · 30d

Cleared Nov 28, 2018

Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks

K183010 · JWH

Smith & Nephew, Inc.

Orthopedic · 28d

Cleared Nov 27, 2018

AdVance XP Male Sling

K182169 · OTM

Boston Scientific Corporation

Gastroenterology & Urology · 109d

Cleared Nov 27, 2018

EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay

K182353 · LJM

Phadia AB

Immunology · 90d

Cleared Nov 27, 2018

gammaCore Sapphire

K182369 · PKR

Electrocore, Inc.

Neurology · 88d

Cleared Nov 27, 2018

ATEC ALIF and LLIF Spacer System

K182746 · MAX

Alphatec Spine, Inc.

Orthopedic · 60d

Cleared Nov 27, 2018

Biop Digital Colposcope

K182764 · HEX

Biop Medical , Ltd.

Obstetrics & Gynecology · 60d

Cleared Nov 27, 2018

Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator...

K182801 · GEI

Integra LifeSciences Corporation

General & Plastic Surgery · 56d

Cleared Nov 27, 2018

iFuse Implant System®

K182983 · OUR

SI-BONE, Inc.

Orthopedic · 29d

Cleared Nov 26, 2018

Low-frequency Multi-function physiotherapy instrument

K172837 · NUH

Shenzhen Osto Technology Co., Ltd.

Neurology · 433d

Cleared Nov 26, 2018

Orchestrate 3D

K181112 · PNN

Orchestrate 3D

Dental · 213d

Cleared Nov 26, 2018

ARiX RAD Radiographic System

K182134 · KPR

Compania Mexicana DE Radiologia Cgr,...

Radiology · 112d

Cleared Nov 26, 2018

EkoSonic Endovascular System

K182324 · QEY

Btg International, Inc.

Cardiovascular · 91d

Cleared Nov 26, 2018

TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws

K182346 · MBH

Exactech, Inc.

Orthopedic · 90d

Cleared Nov 26, 2018

Konicaminolta DI-X1

K182431 · LLZ

Konica Minolta, Inc.

Radiology · 81d

Cleared Nov 26, 2018

Plateau Spacer System

K182470 · MAX

Life Spine

Orthopedic · 77d

Cleared Nov 26, 2018

Selethru PTCA Balloon Dilatation Catheter

K182699 · LOX

Kossel Medtech (Suzhou) Co., Ltd.

Cardiovascular · 60d

Cleared Nov 26, 2018

HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE...

K183009 · GEI

Hemostatix Medical Technologies, LLC

General & Plastic Surgery · 26d

Cleared Nov 26, 2018

Vitrea Software Package, VSTP-001A

K183013 · LLZ

Canon Medical Systems Corporation

Radiology · 26d

Cleared Nov 26, 2018

Corin Optimized Positioning System (OPS) Plan

K183038 · LLZ

Corin USA

Radiology · 25d

Cleared Nov 26, 2018

3M Clarity Aligners

K183159 · NXC

3M Company

Dental · 11d