Search FDA 510(k) Database

Cleared Nov 26, 2018

FlexCath Advance Steerable Sheath and Dilator

K183174 · DRA

Medtronic Cryocath, LP

Cardiovascular · 10d

Cleared Nov 23, 2018

Digistat Smart Central

K180430 · MSX

Ascom Ums Srl Unipersonale

Cardiovascular · 280d

Cleared Nov 23, 2018

Greene Renal Transplant Stent Set

K180557 · FAD

Cook Incorporated

Gastroenterology & Urology · 267d

Cleared Nov 23, 2018

Responsive Arthroscopy Interference Screw System

K180573 · HWC

Responsive Arthroscopy, LLC

Orthopedic · 263d

Cleared Nov 23, 2018

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit

K180607 · PCG

Kronus, Inc.

Immunology · 261d

Cleared Nov 23, 2018

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)

K180643 · FRO

Medcu Technologies , Ltd.

General & Plastic Surgery · 256d

Cleared Nov 23, 2018

A.B. Dental Devices Dental Implants System

K181381 · NHA

A.B. Dental Device , Ltd.

Dental · 183d

Cleared Nov 23, 2018

Accula RSV Test

K181443 · OCC

Mesa Biotech, Inc.

Microbiology · 176d

Cleared Nov 23, 2018

Hyper GP (tisilfocon A) Daily Wear Contact Lens

K182304 · HQD

Contamac, Ltd.

Ophthalmic · 91d

Cleared Nov 23, 2018

HammerTechTM Fixation System

K182684 · HWC

Fusion Orthopedics, LLC

Orthopedic · 58d

Cleared Nov 23, 2018

Motion Tracking and Compensation Feature for the Radixact Treatment Delivery...

K182687 · IYE

Accuray Incorporated

Radiology · 58d

Cleared Nov 23, 2018

Visor System

K182967 · QAF

Cerebrotech Medical Systems, Inc.

Neurology · 28d

Cleared Nov 22, 2018

Sunkingdom Slit Lamp

K182306 · HJO

Chongqing Sunkingdom Medical...

Ophthalmic · 90d

Cleared Nov 21, 2018

ProFuse CAD

K173744 · LLZ

Eigen

Radiology · 349d

Cleared Nov 21, 2018

DePuy Synthes 2.0 mm Quick Insertion Screws

K180541 · HWC

Synthes USA Products, LLC

Orthopedic · 265d

Cleared Nov 21, 2018

Jet Power Injectable PICC

K180546 · LJS

Jet Medical, Inc.

General Hospital · 265d

Cleared Nov 21, 2018

ApnoDent Appliance

K181123 · LRK

Apnomed, Inc.

Dental · 205d

Cleared Nov 21, 2018

DENTIOIII series (DENTIOIII, DENTIOIII-S)

K181297 · MUH

Hdx Will Corp.

Radiology · 189d

Cleared Nov 21, 2018

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES...

K181454 · LPL

Alcon Laboratories, Inc.

Ophthalmic · 170d

Cleared Nov 21, 2018

Transpara

K181704 · QDQ

Screenpoint Medical B.V.

Radiology · 147d

Cleared Nov 21, 2018

MATRx Plus

K181996 · MNR

Zephyr Sleep Technologies

Anesthesiology · 118d

Cleared Nov 21, 2018

Wet Organics Personal Lubricant

K182027 · NUC

Trigg Laboratories Dba Wet International

Obstetrics & Gynecology · 114d

Cleared Nov 21, 2018

Versana Premier

K182277 · IYN

GE Medical Systems Ultrasound and...

Radiology · 91d

Cleared Nov 21, 2018

SP-LINK™ System

K182352 · PEK

Medical Designs, LLC

Orthopedic · 84d