Search FDA 510(k) Database

Cleared Jun 03, 2019

Solanas® Posterior OCT Fixation System

K191185 · NKG

Alphatec Spine

Orthopedic · 31d

Cleared Jun 02, 2019

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose...

K190564 · NBW

Bionime Corporation

Chemistry · 89d

Cleared Jun 01, 2019

Erchonia FX-635

K190572 · NHN

Erchonia Corporation

Physical Medicine · 87d

Cleared May 31, 2019

Pristine Hemodialysis Catheter

K182443 · MSD

Pristine Access Technologies , Ltd.

Gastroenterology & Urology · 266d

Cleared May 31, 2019

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling

K182678 · LPH

Zimmer, Inc.

Orthopedic · 247d

Cleared May 31, 2019

Apis

K182725 · FRO

Sweetbio, Inc.

General & Plastic Surgery · 245d

Cleared May 31, 2019

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon...

K190194 · GEH

Pentax Medical, A Division of Pentax...

General & Plastic Surgery · 116d

Cleared May 31, 2019

Tiger Sharps Containers

K190240 · MMK

International Marketing Specialists,...

General Hospital · 114d

Cleared May 31, 2019

NeuroShield

K190246 · JXI

Monarch Bioimplants GmbH

Neurology · 114d

Cleared May 31, 2019

U Deliver Bolink ENFit Enteral Feeding Sets

K190310 · PIF

U Deliver Medical, LLC

Gastroenterology & Urology · 108d

Cleared May 31, 2019

Cannulated Hemi Implant

K190543 · KWD

Vilex IN Tennessee, Inc.

Orthopedic · 88d

Cleared May 31, 2019

NEXXT MATRIXX Stand Alone Cervical System

K190546 · OVE

Nexxt Spine, LLC

Orthopedic · 87d

Cleared May 31, 2019

Cervical Plate

K190565 · KWQ

Eisertech, LLC

Orthopedic · 87d

Cleared May 31, 2019

MAGNETOM Avanto Fit

K190757 · LNH

Siemens Medical Solution USA, Inc.

Radiology · 67d

Cleared May 31, 2019

PALACOS fast R+G

K190766 · LOD

Heraeus Medical GmbH

Orthopedic · 67d

Cleared May 31, 2019

E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A...

K190831 · GCJ

Nanjing Jusha Display Technology Co.,...

General & Plastic Surgery · 60d

Cleared May 31, 2019

BriefCase

K190896 · QAS

Aidoc Medical , Ltd.

Radiology · 56d

Cleared May 30, 2019

Air Relax

K173158 · IRP

Maxstar Industrial Co., Ltd.

Physical Medicine · 608d

Cleared May 30, 2019

Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with...

K182308 · LZA

Sri Trang Gloves (Thailand) Co., Ltd.

General Hospital · 279d

Cleared May 30, 2019

Qangio XA 3D

K182611 · QHA

Medis Medical Imaging Systems BV

Radiology · 251d

Cleared May 30, 2019

GaltTWS

K182660 · DRB

Galt Medical Corp.

Cardiovascular · 247d

Cleared May 30, 2019

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC...

K183205 · JQC

Emcyte Corporation

Hematology · 192d

Cleared May 30, 2019

neXus Ultrasonic Surgical Aspirator System

K190160 · LFL

Misonix, Inc.

General & Plastic Surgery · 120d

Cleared May 30, 2019

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical...

K190623 · OCL

Medtronic

Cardiovascular · 80d