Search FDA 510(k) Database

Cleared Nov 16, 2018

1.5T 16ch Breast Coil

K182958 · MOS

Neocoil, LLC

Radiology · 23d

Cleared Nov 16, 2018

Zilver 518 Biliary Stent, Zilver 635 Biliary Stent

K182980 · FGE

Cook Ireland, Ltd.

Gastroenterology & Urology · 18d

Cleared Nov 15, 2018

K2 Zirkon Blank white classic

K173971 · EIH

Yeti Dentalprodukte GmbH

Dental · 321d

Cleared Nov 15, 2018

Amsel Endo Occluder

K180650 · FZP

Amsel Medical Corporation

General & Plastic Surgery · 247d

Cleared Nov 15, 2018

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N

K180668 · FCG

Olympus Medical Systems Corp.

Gastroenterology & Urology · 246d

Cleared Nov 15, 2018

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor

K181292 · EOX

Cogentix Medical, Inc.

Ear, Nose, Throat · 183d

Cleared Nov 15, 2018

FilmArray Pneumonia Panel plus

K181324 · QDS

Biofire Diagnostics, LLC

Microbiology · 181d

Cleared Nov 15, 2018

Nexcomp

K181689 · EBF

Meta Biomed Co., Ltd.

Dental · 142d

Cleared Nov 15, 2018

SITZMARKS

K181750 · FFX

Konsyl Pharmaceuticals

Gastroenterology & Urology · 136d

Cleared Nov 15, 2018

IntelliVue Multi-Measurement Module MMX

K181831 · MHX

Philips Medizin Systeme Boeblingen GmbH

Cardiovascular · 129d

Cleared Nov 15, 2018

Reprocessed Marinr Diagnostic EP Catheter

K181897 · NLH

Innovative Health, LLC

Cardiovascular · 122d

Cleared Nov 15, 2018

Voluson E6, Voluson E8, Voluson E10

K181985 · IYN

Ge Healthcare

Radiology · 113d

Cleared Nov 15, 2018

CardioBand ECG Event Recorder

K181998 · DPS

Samsung Strategy and Innovation...

Cardiovascular · 112d

Cleared Nov 15, 2018

YUKON OCT Spinal System

K182182 · NKG

K2m

Orthopedic · 94d

Cleared Nov 15, 2018

CanGaroo Neuro Envelope (small)

K182255 · FTM

Aziyo Biologics, Inc.

General & Plastic Surgery · 87d

Cleared Nov 15, 2018

Nitrile Glove Powder Free Black

K182528 · LZA

Haining Medical Products Co., Ltd.

General Hospital · 62d

Cleared Nov 15, 2018

PathLoc-L MIS Spinal System

K183117 · NKB

L & K Biomed Co., Ltd.

Orthopedic · 6d

Cleared Nov 14, 2018

Miracu

K172602 · NEW

Feeltech Co., Ltd.

General & Plastic Surgery · 441d

Cleared Nov 14, 2018

Apoller Flow Light Cure Flowable Composite

K180463 · EBF

Greenway Yw, LLC

Dental · 266d

Cleared Nov 14, 2018

Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs

K181090 · IOR

Invacare Corporation

Physical Medicine · 203d

Cleared Nov 14, 2018

SporView Rapid Read Biological Indicator SteamPlus Test Pack

K181434 · FRC

Crosstex/Spsmedical, A Division of...

General Hospital · 166d

Cleared Nov 14, 2018

HPM-6000UF

K181497 · KPI

BTL Industries, Inc.

Gastroenterology & Urology · 160d

Cleared Nov 14, 2018

Velofix TLIF Cage

K181829 · MAX

U&I Corporation

Orthopedic · 128d

Cleared Nov 14, 2018

Inversa Implants

K181850 · DZE

Southern Implants (Pty), Ltd.

Dental · 126d