Search FDA 510(k) Database

Cleared Dec 03, 2018

IMPLANTER DENTAL PLANNING SOFTWARE

K173083 · LLZ

Implanter, LLC

Radiology · 430d

Cleared Dec 03, 2018

LZI Fentanyl Enzyme Immunoassay

K181159 · DJG

Lin-Zhi International, Inc.

Toxicology · 216d

Cleared Dec 03, 2018

Action Trackchair

K181908 · ITI

Action Manufacturing, Inc.

Physical Medicine · 139d

Cleared Dec 03, 2018

Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles,...

K182146 · FMI

Sol-Millennium Medical, Inc.

General Hospital · 117d

Cleared Dec 03, 2018

Wondfo T-Cup Multi-Drug Urine Test Cup

K182701 · NFT

Guangzhou Wondfo Biotech Co., Ltd.

Toxicology · 67d

Cleared Nov 30, 2018

Single Use Hot Biopsy Forceps FD-231

K173495 · QEC

Olympus Medical Systems Corp.

Anesthesiology · 382d

Cleared Nov 30, 2018

Prizma

K173589 · DXH

G-Medical Innovations , Ltd.

Cardiovascular · 375d

Cleared Nov 30, 2018

welloStationX

K180298 · FLL

Wello, Inc.

General Hospital · 301d

Cleared Nov 30, 2018

Transcend 365 miniCPAP System

K180388 · BZD

Somnetics International, Inc.

Anesthesiology · 290d

Cleared Nov 30, 2018

ZOLL Propaq M

K180482 · MHX

ZOLL Medical Corporation

Cardiovascular · 280d

Cleared Nov 30, 2018

Tinnitus Sound Generator Module

K180495 · KLW

GN Hearing A/S

Ear, Nose, Throat · 277d

Cleared Nov 30, 2018

Arterial Pressure Monitoring Set/Tray

K180792 · DQO

Cook Incorporated

Cardiovascular · 248d

Cleared Nov 30, 2018

UNO Negative Pressure Wound Therapy System

K180840 · OMP

Genadyne Biotechnologies, Inc.

General & Plastic Surgery · 245d

Cleared Nov 30, 2018

Planmed Verity

K180918 · OAS

Planmed OY

Radiology · 235d

Cleared Nov 30, 2018

BD PhaSeal Optima Closed System Transfer Device

K181221 · ONB

Becton, Dickinson and Company

General Hospital · 207d

Cleared Nov 30, 2018

Ambu aScope RLS Slim

K181286 · EOB

Ambu A/S

Ear, Nose, Throat · 198d

Cleared Nov 30, 2018

Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with...

K181524 · BZC

Vyaire Medical, Inc.

Anesthesiology · 172d

Cleared Nov 30, 2018

POPS! one Blood Glucose Monitoring System

K181588 · NBW

Taidoc Technology Corporation

Chemistry · 168d

Cleared Nov 30, 2018

ChitoZolve

K181696 · LYA

Gyrus Acmi, Inc.

Ear, Nose, Throat · 156d

Cleared Nov 30, 2018

Spectra S3 Plus

K181784 · HGX

Uzinmedicare Co.

Obstetrics & Gynecology · 150d

Cleared Nov 30, 2018

Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood...

K182046 · NBW

Tyson Bioresearch, Inc.

Chemistry · 122d

Cleared Nov 30, 2018

FerriSmart Analysis System

K182218 · PCS

Resonance Health Analysis Services...

Radiology · 107d

Cleared Nov 30, 2018

EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or...

K182245 · DXN

Edwards Lifesciences, LLC

Cardiovascular · 102d

Cleared Nov 30, 2018

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens

K182249 · LPL

Bausch & Lomb, Incorporated

Ophthalmic · 102d