Search FDA 510(k) Database

Cleared Apr 02, 2020

ARC 400

K193591 · GEI

Bowa-Electronics GmbH & Co. KG

General & Plastic Surgery · 101d

Cleared Apr 02, 2020

FilmArray BCID2 Control Panel M416

K200010 · PMN

Maine Molecular Quality Controls, Inc.

Microbiology · 91d

Cleared Apr 02, 2020

Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System

K200251 · IYN

Shenzhen Mindray Bio-Medical...

Radiology · 59d

Cleared Apr 02, 2020

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin...

K200319 · FMT

Deroyal Industries, Inc.

General Hospital · 55d

Cleared Apr 02, 2020

EVOS Lumbar Interbody System

K200552 · MAX

Cutting Edge Spine, LLC

Orthopedic · 30d

Cleared Apr 02, 2020

FIREBIRD SI Fusion System

K200696 · OUR

Orthofix, Inc.

Orthopedic · 16d

Cleared Apr 01, 2020

Venus VivaTM

K191065 · GEI

Venus Concept USA, Inc.

General & Plastic Surgery · 345d

Cleared Apr 01, 2020

Magnetic Surgical System

K191762 · PNL

Levita Magnetics International Corp

General & Plastic Surgery · 275d

Cleared Apr 01, 2020

CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical...

K192228 · PSW

Cs Medical, LLC

General Hospital · 229d

Cleared Apr 01, 2020

Manual Wheelchair

K192658 · IOR

Jerry Medical Instrument (Shanghai)...

Physical Medicine · 189d

Cleared Apr 01, 2020

Introcan Safety 2 IV Catheter 18-24 gauge

K192676 · FOZ

B.Braun Medical, Inc.

General Hospital · 188d

Cleared Apr 01, 2020

Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove...

K192988 · KGO

Medline Industries, Inc.

General Hospital · 159d

Cleared Apr 01, 2020

VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer...

K193580 · ONN

Orthosensor, Inc.

Orthopedic · 100d

Cleared Apr 01, 2020

LOGIQ E10s

K200119 · IYN

GE Medical Systems Ultrasound and...

Radiology · 71d

Cleared Apr 01, 2020

DSI Dental Implant System

K200188 · DZE

Dsi Dental Solutions, Ltd.

Dental · 68d

Cleared Apr 01, 2020

SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All,...

K200524 · JAK

Siemens Medical Solutions USA, Inc.

Radiology · 30d

Cleared Apr 01, 2020

Focus 43C detector, TRIMAX 43C detector

K200622 · MQB

Iray Technology Taicang , Ltd.

Radiology · 23d

Cleared Mar 31, 2020

da Vinci X and Xi Surgical System

K183086 · NAY

Intuitive Surgical, Inc.

General & Plastic Surgery · 511d

Cleared Mar 31, 2020

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis...

K191860 · KGO

Semperit Technische Produkte...

General Hospital · 264d

Cleared Mar 31, 2020

iCEWav Neuromonitoring Platform

K191868 · GWQ

Ice Neurosystems, Inc.

Neurology · 263d

Cleared Mar 31, 2020

SiteSeal Femoral Compression Device

K192413 · DXC

Ensite Vacular, LLC

Cardiovascular · 209d

Cleared Mar 31, 2020

Vertaplex HV High Viscosity Radiopaque Bone Cement

K192818 · PML

Stryker Corporation

Orthopedic · 182d

Cleared Mar 31, 2020

Sectra Digital Pathology Module

K193054 · QKQ

Sectra AB

Pathology · 151d

Cleared Mar 31, 2020

Rapid ICH

K193087 · QAS

Ischemaview Incorporated

Radiology · 146d