Search FDA 510(k) Database

Cleared Apr 13, 2020

CuraRad-ICH

K192167 · QAS

Curacloud Corp.

Radiology · 248d

Cleared Apr 13, 2020

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium...

K192838 · DWA

Spectrum Medical , Ltd.

Cardiovascular · 193d

Cleared Apr 13, 2020

Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal...

K192850 · KFM

Qura S.R.L

Cardiovascular · 193d

Cleared Apr 13, 2020

ND:YAG Laser

K193464 · GEX

Beijing Superlaser Technology Co., Ltd.

General & Plastic Surgery · 119d

Cleared Apr 13, 2020

s-Clean SQ-SL Implant System Mini

K200099 · DZE

Dentis Co., Ltd.

Dental · 88d

Cleared Apr 13, 2020

ADVIA Centaur CEA Assay

K200215 · DHX

Siemens Healthcare Disgnostics, Inc.

Immunology · 76d

Cleared Apr 13, 2020

VivAer Stylus

K200300 · GEI

Aerin Medical, Inc.

Ear, Nose, Throat · 67d

Cleared Apr 13, 2020

AcuityPDR

K200726 · IZL

Radmedix, LLC

Radiology · 24d

Cleared Apr 12, 2020

VERASENSE for Stryker Triathlon

K200665 · ONN

Orthosensor, Inc.

Orthopedic · 30d

Cleared Apr 11, 2020

Nerve and Muscle Stimulator

K193275 · IPF

Shenzhen Xft Medical Limited

Physical Medicine · 137d

Cleared Apr 10, 2020

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

K190353 · PLC

Residential Home Sleep Services

Dental · 420d

Cleared Apr 10, 2020

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single...

K192679 · MEG

Gemtier Medical (Shanghai), Inc.

General Hospital · 197d

Cleared Apr 10, 2020

Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition...

K193215 · LNH

Philips Medical Systems Nederland B.V.

Radiology · 141d

Cleared Apr 10, 2020

SIGNA Premier

K193282 · LNH

Ge Healthcare (Ge Medical Systems, LLC)

Radiology · 135d

Cleared Apr 10, 2020

Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI...

K193573 · KGO

Molnlycke Health Care Us, LLC

General Hospital · 109d

Cleared Apr 10, 2020

SkinStylus SteriLock MicroSystem

K200044 · QAI

Esthetic Education, LLC

General & Plastic Surgery · 93d

Cleared Apr 10, 2020

KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with...

K200072 · LZA

Kimberly Clark Corporation

General Hospital · 87d

Cleared Apr 10, 2020

VARO Plan

K200078 · LLZ

3D Industrial Imaging Co., Ltd.

Radiology · 87d

Cleared Apr 10, 2020

Zimmer Hip Joint Replacement

K200112 · LZO

Zimmer GmbH

Orthopedic · 84d

Cleared Apr 10, 2020

OrthAlign Plus System

K200642 · OLO

Orthalign, Inc.

Orthopedic · 30d

Cleared Apr 10, 2020

ACUSON Freestyle Diagnostic Ultrasound System

K200644 · IYN

Siemens Medical Solutions USA, Inc.

Radiology · 30d

Cleared Apr 10, 2020

DR-ID 1200SDK System

K200668 · MQB

Fujifilm Corporation

Radiology · 28d

Cleared Apr 09, 2020

OxSAT 100

K191574 · DQA

S.L.P. , Ltd.

Anesthesiology · 300d

Cleared Apr 09, 2020

ATLAS Plating System

K191867 · HRS

MiRus, LLC

Orthopedic · 272d