Search FDA 510(k) Database

Cleared Jul 31, 2019

EyeBOX

K191183 · QEA

Oculogica, Inc.

Neurology · 90d

Cleared Jul 31, 2019

Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent...

K191510 · DHB

Hycor Biomedical

Immunology · 55d

Cleared Jul 31, 2019

Diode Laser Therapy Systems

K191611 · GEX

Wingderm Electro-Optics , Ltd.

General & Plastic Surgery · 44d

Cleared Jul 31, 2019

Mobius3D

K191761 · IYE

Varian Medical Systems, Inc.

Radiology · 30d

Cleared Jul 31, 2019

Inion BioRestore

K191764 · MQV

Inion OY

Orthopedic · 30d

Cleared Jul 31, 2019

GORE BIO-A Tissue Reinforcement

K191773 · OWT

W.L. Gore & Associates, Inc.

General & Plastic Surgery · 29d

Cleared Jul 31, 2019

AOCup Lens Case with AODisc

K191795 · LPN

Alcon Laboratories, Inc.

Ophthalmic · 28d

Cleared Jul 31, 2019

HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)

K191931 · JTN

Hardy Diagnostics

Microbiology · 12d

Cleared Jul 30, 2019

Hamilton-G5

K180295 · CBK

Hamiton Medical AG

Anesthesiology · 544d

Cleared Jul 30, 2019

Blood Transfer Accessory (BTA)

K181743 · JKA

Nsp Tech Pte, Ltd.

General Hospital · 393d

Cleared Jul 30, 2019

Blood Collection Accessory (BUCA)

K181754 · JKA

Nsp Tech Pte, Ltd.

General Hospital · 393d

Cleared Jul 30, 2019

Powder Free Blue Nitrile Examination Gloves - Tested for Use with...

K182089 · LZA

Platinum Glove Industries Sdn. Bhd.

General Hospital · 362d

Cleared Jul 30, 2019

Transcutaneous Electrical Nerve Stimulator

K183288 · NUH

Shenzhen Kentro Medical Electronics...

Neurology · 246d

Cleared Jul 30, 2019

Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable...

K183547 · DRF

Medtronic

Cardiovascular · 222d

Cleared Jul 30, 2019

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

K190132 · DRF

Medtronic

Cardiovascular · 183d

Cleared Jul 30, 2019

Endotracheal Tube

K190274 · BTR

Tianjin Medis Medical Device Co., Ltd.

Anesthesiology · 172d

Cleared Jul 30, 2019

Addivation Medical Cervical Interbody System

K190291 · ODP

Addivation Medical, LLC

Orthopedic · 169d

Cleared Jul 30, 2019

Atellica CH Amylase_2 (AMY_2)

K191454 · JFJ

Siemens Healthcare Diagnostics, Inc.

Chemistry · 60d

Cleared Jul 30, 2019

Renuvion/J-Plasma Precise Handpiece

K191484 · GEI

Apyx Medical Corporation(Formerly...

General & Plastic Surgery · 56d

Cleared Jul 30, 2019

AXS Vecta Aspiration System

K191768 · NRY

Stryker Neurovascular

Neurology · 29d

Cleared Jul 29, 2019

Quantisal II Oral Fluid Collection Device

K183048 · PJD

Immunalysis Corporation

Chemistry · 269d

Cleared Jul 29, 2019

Helioseal F Plus

K190339 · EBC

Ivoclar Vivadent, AG

Dental · 165d

Cleared Jul 29, 2019

Shaders ZR

K190569 · EIH

Digital Age Dental Lab

Dental · 145d

Cleared Jul 29, 2019

Sample Imaging for Senographe Pristina

K190809 · MUE

Ge Healthcare

Radiology · 122d