Search FDA 510(k) Database

Cleared Sep 13, 2018

Planmeca Viso

K181576 · OAS

Planmeca Oy

Radiology · 90d

Cleared Sep 13, 2018

Spectralis HRA+OCT and variants with OCT Angiography Module

K181594 · OBO

Heidelberg Engineering GmbH

Ophthalmic · 87d

Cleared Sep 13, 2018

MOSS VRS Spinal System

K181821 · NKB

Biedermann Motech GmbH & Co. KG

Orthopedic · 66d

Cleared Sep 13, 2018

MTS Penicillin 0.002- 32 µg/mL

K181889 · JWY

Liofilchem S. R. L.

Microbiology · 62d

Cleared Sep 13, 2018

RiX70 DC

K182206 · EHD

Trident S.R.L

Radiology · 29d

Cleared Sep 13, 2018

Seal Single Use Biopsy Valve

K182275 · OCX

Boston Scientific Corporation

Gastroenterology & Urology · 22d

Cleared Sep 12, 2018

BioSphere Flex

K173424 · MQV

Synergy Biomedical

Orthopedic · 315d

Cleared Sep 12, 2018

PRODENSE Bone Graft Substitute

K181255 · MQV

Wrightmedicaltechnologyinc

Orthopedic · 124d

Cleared Sep 12, 2018

Magnesium

K181748 · JGJ

Abbott Laboratories

Chemistry · 72d

Cleared Sep 11, 2018

TruBase S

K171532 · NHA

Truabutment, Inc.

Dental · 474d

Cleared Sep 11, 2018

Anchor Tissue Retrieval System by CONMED

K173822 · GCJ

Conmed Corporation

Obstetrics & Gynecology · 267d

Cleared Sep 11, 2018

LnK Lumbar Interbody Fusion Cage System

K181380 · MAX

L & K Biomed Co., Ltd.

Orthopedic · 110d

Cleared Sep 11, 2018

Stryker Pediatric Mandibular Distractor 2

K181504 · MQN

Stryker

Dental · 96d

Cleared Sep 11, 2018

IPL Salon Hair Reduction System

K181568 · OHT

Medical Device Branch of Zhangzhou...

General & Plastic Surgery · 89d

Cleared Sep 11, 2018

Renovis S180 Lateral Lumbar Interbody Fusion System

K181655 · MAX

Renovis Surgical Technologies

Orthopedic · 81d

Cleared Sep 11, 2018

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope...

K182196 · DQD

Imediplus, Inc.

Cardiovascular · 28d

Cleared Sep 11, 2018

AirStrip RPM InvisionHeart Adapter

K182226 · MWI

Airstrip Technologies, Inc.

Cardiovascular · 26d

Cleared Sep 11, 2018

Octane Mechanical Thrombectomy System

K182232 · QEZ

Vascular Solutions, Inc.

Cardiovascular · 25d

Cleared Sep 10, 2018

IntelliSpace Perinatal Rev.K.00

K173941 · HGM

Philips Medizin Systeme Boeblingen GmbH

Obstetrics & Gynecology · 258d

Cleared Sep 10, 2018

The Sex Gel

K181078 · NUC

Necessaire, Inc.

Obstetrics & Gynecology · 139d

Cleared Sep 10, 2018

Human Tecar HCR 1002

K181211 · PBX

Unibell S.R.L

General & Plastic Surgery · 126d

Cleared Sep 10, 2018

XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0

K181415 · OWB

Canon Medical Systems Corporation

Radiology · 103d

Cleared Sep 10, 2018

ProSun sunlamp products, Luxura sunlamp products

K181455 · LEJ

Prosun International, LLC

General & Plastic Surgery · 98d

Cleared Sep 10, 2018

SECULOK™ ACP System

K182055 · KWQ

U&I Corporation

Orthopedic · 41d