Search FDA 510(k) Database

Cleared Feb 13, 2019

U&U Blood Collection Sets

K181508 · FMI

U&U Medical Technology Co, Ltd.

General Hospital · 251d

Cleared Feb 13, 2019

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

K181661 · OYX

Bio-Rad Laboratories, Inc.

Medical Genetics · 233d

Cleared Feb 13, 2019

Kava and Kava with Herbst

K182661 · LRK

Sketchpad Innovations, LLC

Dental · 141d

Cleared Feb 13, 2019

Fenom Pro Nitric Oxide Test

K182874 · MXA

Spirosure, Inc.

Chemistry · 124d

Cleared Feb 13, 2019

ENvizion Medical ENvue

K182915 · KNT

Envizion Medical , Ltd.

Gastroenterology & Urology · 118d

Cleared Feb 13, 2019

NuVasive Reline System

K182974 · NKB

Nu Vasive, Incorporated

Orthopedic · 110d

Cleared Feb 13, 2019

EPIC Extremity Fusion Plate System

K182991 · HRS

Epic Extremity, LLC

Orthopedic · 107d

Cleared Feb 13, 2019

SnapShot Freeze 2

K183161 · JAK

Ge Medical Systems, LLC

Radiology · 90d

Cleared Feb 12, 2019

WiEMSpro

K181955 · NGX

Medical Cables S.L.

Physical Medicine · 204d

Cleared Feb 12, 2019

FORA P100 Blood Pressure Monitoring System

K182934 · DXN

Taidoc Technology Corporation

Cardiovascular · 113d

Cleared Feb 12, 2019

MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam...

K183127 · LTT

Beckman Coulter, Inc.

Microbiology · 91d

Cleared Feb 12, 2019

Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens

K183167 · HQD

Bausch & Lomb, Incorporated

Ophthalmic · 89d

Cleared Feb 12, 2019

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium...

K183375 · JJE

Horiba, Ltd.

Chemistry · 68d

Cleared Feb 12, 2019

Cruxcan (CRX-1000)

K183637 · MUH

Cruxell Corp.

Radiology · 48d

Cleared Feb 12, 2019

KOWA VK-2s

K190056 · NFJ

Kowa Co. Ltd. Chofu

Ophthalmic · 32d

Cleared Feb 12, 2019

Aurora Evacuator

K190075 · GEI

Rebound Therapeutics

General & Plastic Surgery · 27d

Cleared Feb 11, 2019

TrueDorsal Devices

K180691 · LRK

True Function Laboratory, Inc.

Dental · 332d

Cleared Feb 11, 2019

Cemented TSI Hip Stem

K181340 · JDI

Signature Orthopaedics Pty, Ltd.

Orthopedic · 266d

Cleared Feb 11, 2019

SMG Anterior Cervical Plate System

K183073 · KWQ

Sapphire Medical Group

Orthopedic · 98d

Cleared Feb 11, 2019

BacT/ALERT FA Plus

K183166 · MDB

bioMerieux, Inc.

Microbiology · 88d

Cleared Feb 11, 2019

HANAROSTENT FASTTM Biliary (NNN)

K183396 · FGE

M.I. Tech Co., Ltd.

Gastroenterology & Urology · 66d

Cleared Feb 11, 2019

Athena II Cervical Plate System

K183409 · KWQ

Medyssey USA, Inc.

Orthopedic · 63d

Cleared Feb 11, 2019

easyPPHTM Hemorrhoidal Stapler for Single Use

K183477 · GDW

Ezisurg Medical Co., Ltd.

General & Plastic Surgery · 56d

Cleared Feb 11, 2019

Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion...

K183557 · ODP

Titan Spine, Inc.

Orthopedic · 53d