Search FDA 510(k) Database

Cleared Jun 05, 2020

Voyant Open Fusion Device

K201212 · GEI

Applied Medical Resources Corp.

General & Plastic Surgery · 31d

Cleared Jun 04, 2020

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...

K193555 · LZC

Ever Global (Vietnam) Enterprise Corp

General Hospital · 167d

Cleared Jun 04, 2020

bioli lOL Delivery System

K200057 · MSS

Ast Products, Inc.

Ophthalmic · 143d

Cleared Jun 04, 2020

Oxylight

K200104 · GEX

Raja Trading Company, Inc.

General & Plastic Surgery · 139d

Cleared Jun 04, 2020

Journey II XR Knee Instrument

K200227 · JWH

Smith & Nephew, Inc.

Orthopedic · 126d

Cleared Jun 04, 2020

Livongo Blood Glucose Monitoring System (BG1000)

K200277 · NBW

Livongo Health, Inc.

Chemistry · 121d

Cleared Jun 04, 2020

CarboClear® Cervical Plate System

K200883 · KWQ

CarboFix Orthopedics , Ltd.

Orthopedic · 63d

Cleared Jun 04, 2020

HEALIX ADVANCE Anchor with DYNATAPE Suture

K200949 · MBI

Medos International SARL

Orthopedic · 56d

Cleared Jun 04, 2020

t:slim X2 Insulin Pump with Interoperable Technology

K201214 · QFG

Tandem Diabetes Care, Inc.

Chemistry · 30d

Cleared Jun 04, 2020

LZI Tramadol Enzyme Immunoassay

K201223 · DJG

Lin-Zhi International, Inc.

Toxicology · 29d

Cleared Jun 03, 2020

Flap Fixator, Burr Hole Cover

K192310 · GXR

Ossaware Biotech Co., Ltd.

Neurology · 282d

Cleared Jun 03, 2020

Vantage Orian 1.5T, MRT-1550, V6.0

K193021 · LNH

Canon Medical Systems Corporation

Radiology · 217d

Cleared Jun 03, 2020

AltiVate Anatomic Canal-Sparing (CS) Shoulder

K193226 · PKC

Encore Medical, L.P.

Orthopedic · 194d

Cleared Jun 03, 2020

Halo™ Single-Loop Snare Kit

K200268 · MMX

Argon Medical Devices, Inc.

Cardiovascular · 121d

Cleared Jun 03, 2020

pREBOA-PRO Catheter

K200459 · MJN

Prytime Medical Devices, Inc.

Cardiovascular · 99d

Cleared Jun 03, 2020

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

K200506 · QFO

Chembio Diagnostic Systems

Microbiology · 93d

Cleared Jun 03, 2020

Cardioblate Gemini-s Surgical Ablation Device

K200514 · OCL

Medtronic

Cardiovascular · 93d

Cleared Jun 03, 2020

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant

K200602 · NUC

CC Wellness, LLC

Obstetrics & Gynecology · 86d

Cleared Jun 03, 2020

Agilis HisPro Steerable Catheter With Electrodes

K200721 · DQY

Abbott (St. Jude Medical)

Cardiovascular · 76d

Cleared Jun 03, 2020

Thales 3D Mr Scanner

K200907 · IYE

Lap GmbH Laser Applikationen

Radiology · 58d

Cleared Jun 03, 2020

Hair Growth System

K200929 · OAP

Xuzhou Kernel Medical Equipment Co.,...

General & Plastic Surgery · 57d

Cleared Jun 03, 2020

QLAB Advanced Quantification Software

K200974 · QIH

Philips Health Care

Radiology · 51d

Cleared Jun 03, 2020

StealthStation Cranial Software v1.3.0

K201175 · HAW

Medtronic Navigation, Inc.

Neurology · 33d

Cleared Jun 02, 2020

Bunny Wax Personal Lubricant

K192779 · NUC

Reoxcyn, LLC

Obstetrics & Gynecology · 246d