Search FDA 510(k) Database

Cleared May 21, 2019

MAKO 7

K182975 · HIH

Boston Scientific Corporation

Obstetrics & Gynecology · 208d

Cleared May 21, 2019

ET IV SA Dental Implants

K183242 · DZE

Hiossen, Inc.

Dental · 181d

Cleared May 21, 2019

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen...

K183646 · QAQ

Edwards Lifeciences, LLC

Cardiovascular · 146d

Cleared May 21, 2019

Smith & Nephew Tablet Application

K190367 · QGY

Smith & Nephew

General & Plastic Surgery · 95d

Cleared May 20, 2019

OnSite Waste Sharps Container

K182235 · MMK

Bluestone Medical, Inc.

General Hospital · 276d

Cleared May 20, 2019

VersaCross Transseptal Sheath

K183655 · DYB

Baylis Medical Company, Inc.

Cardiovascular · 144d

Cleared May 20, 2019

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB

K190134 · DXN

Health & Life Co., Ltd.

Cardiovascular · 112d

Cleared May 20, 2019

Aperio AT2 DX System

K190332 · PSY

Leica Biosystems Imaging, Inc.

Pathology · 95d

Cleared May 19, 2019

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire,...

K190125 · MBI

T.A.G. Medical Products Corporation,...

Orthopedic · 111d

Cleared May 18, 2019

QIAstat-Dx Respiratory Panel

K183597 · OCC

QIAGEN GmbH

Microbiology · 148d

Cleared May 17, 2019

SD Abutment

K173570 · NHA

Surgident Co., Ltd.

Dental · 543d

Cleared May 17, 2019

Cook Unimpregnated Central Venous Catheter

K182252 · FOZ

Cook Incorporated

General Hospital · 270d

Cleared May 17, 2019

CardioGard Emboli Protection Cannula

K182302 · DWF

Cardiogard Medical, Ltd.

Cardiovascular · 266d

Cleared May 17, 2019

WiZARD 310/320 Series CPAP Mask

K182394 · BZD

Apex Medical Corp.

Anesthesiology · 255d

Cleared May 17, 2019

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part...

K183035 · LJE

Cook Incorporated

Gastroenterology & Urology · 197d

Cleared May 17, 2019

Delta Xtend Reverse Shoulder System

K183077 · PHX

Depuy(Ireland)

Orthopedic · 193d

Cleared May 17, 2019

Navigation Enabled Instruments

K183381 · OLO

Stryker

Orthopedic · 162d

Cleared May 17, 2019

iRestore Professional 282

K183417 · OAP

Freedom Laser Therapy, Inc.

General & Plastic Surgery · 158d

Cleared May 17, 2019

KY Banksy Moisture

K183505 · NUC

Rb Health (Us), LLC

Obstetrics & Gynecology · 150d

Cleared May 17, 2019

Revolution Radial Head

K183618 · KWI

Ignite Orthopedics, Inc.

Orthopedic · 142d

Cleared May 17, 2019

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

K190675 · MMI

Siemens Healthcare Diagnostics, Inc.

Chemistry · 63d

Cleared May 17, 2019

Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer...

K191015 · MQF

Cook Incorporated

Obstetrics & Gynecology · 30d

Cleared May 17, 2019

DRX-Revolution Mobile X-ray System

K191025 · IZL

Carestream Health, Inc.

Radiology · 29d

Cleared May 17, 2019

Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator...

K191029 · DTZ

Medtronic, Inc.

Cardiovascular · 29d