Search FDA 510(k) Database

Cleared Nov 10, 2020

Nio Fusion 12MP (MDNC-12130)

K203106 · PGY

Barco N.V.

Radiology · 26d

Cleared Nov 09, 2020

BD PureHub Disinfecting Cap

K193190 · QBP

Becton, Dickinson and Company

General Hospital · 356d

Cleared Nov 09, 2020

Vantage PSI System

K193432 · OYK

3D Systems

Orthopedic · 335d

Cleared Nov 09, 2020

Concinnity Aligners

K200005 · NXC

Drake Precision Dental Laboratory, Inc.

Dental · 312d

Cleared Nov 09, 2020

Accula Strep A Test

K201269 · PGX

Mesa Biotech, Inc.

Microbiology · 181d

Cleared Nov 09, 2020

OGYILI TENS/NMES Stimulator

K201431 · GZJ

Gongguan Tutamen Metalwork Co., Ltd.

Neurology · 161d

Cleared Nov 09, 2020

DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound...

K201990 · IYN

Shenzhen Mindray Bio-Medical...

Radiology · 115d

Cleared Nov 09, 2020

Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu...

K202274 · GZB

Boston Scientific Neuromodulation

Neurology · 90d

Cleared Nov 09, 2020

iFuse Implant System - iFuse Navigation

K203110 · OLO

SI-BONE, Inc.

Orthopedic · 25d

Cleared Nov 09, 2020

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC...

K203128 · IYN

Olympus Medical Systems Corp.

Radiology · 21d

Cleared Nov 06, 2020

Medical RF

K192621 · GEI

Triworks Group Srl

General & Plastic Surgery · 410d

Cleared Nov 06, 2020

AI-Rad Companion Organs RT

K193562 · QKB

Siemens Medical Solutions USA, Inc.

Radiology · 319d

Cleared Nov 06, 2020

BioMin Restore Plus

K200077 · LBH

Dr. Collins, Inc.

Dental · 297d

Cleared Nov 06, 2020

Durex Penck Standard, Durex Penck XL

K200672 · HIS

Rb Health (Us), LLC

Obstetrics & Gynecology · 238d

Cleared Nov 06, 2020

Neuro.Al Algorithm

K200750 · LLZ

Terarecon,Inc.

Radiology · 228d

Cleared Nov 06, 2020

cobas u 701 microscopy analyzer

K200811 · LKM

Roche Diagnostics

Hematology · 224d

Cleared Nov 06, 2020

V-Print splint

K201091 · MQC

Voco GmbH

Dental · 197d

Cleared Nov 06, 2020

SimpleSENSE

K201669 · DXH

Nanowear, Inc.

Cardiovascular · 140d

Cleared Nov 06, 2020

Aqueduct 100 Plus Cervical Dilation Balloon Catheter

K202427 · PON

Gtimd, LLC

Obstetrics & Gynecology · 73d

Cleared Nov 06, 2020

BioShield biopsy valve EUS - Linear

K202583 · ODD

STERIS Corporation

Gastroenterology & Urology · 59d

Cleared Nov 06, 2020

ATEC Lateral Interbody System

K202587 · MAX

Alphatec Spine, Inc.

Orthopedic · 59d

Cleared Nov 06, 2020

APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression...

K202589 · HWC

Medartis AG

General Hospital · 59d

Cleared Nov 06, 2020

Clio Prime and Clio Pedo

K202664 · MUH

Sota Precision Optics, Inc. Dba Sota...

Radiology · 53d

Cleared Nov 06, 2020

Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution...

K203061 · FLE

STERIS Corporation

General Hospital · 29d