FDA 510(k) Searchable Database - Search 175,000+ Clearances

Cleared Nov 03, 2003

SPI EASY DENTAL IMPLANT PROTECTIVE CAP

K033346 · NHA

Thommen Medical AG

Dental · 14d

Cleared Oct 31, 2003

DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS

K013452 · MVA

Danmar Products, Inc.

Neurology · 743d

Cleared Oct 31, 2003

SUN-RAIN ULTRASONIC THERAPY, SU-100

K024013 · IMI

Sun-Rain System Corp.

Physical Medicine · 331d

Cleared Oct 31, 2003

KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K030358 · DXN

Kodon(Tianjin)Electronic&Electrical...

Cardiovascular · 270d

Cleared Oct 31, 2003

NIPRO DISPOSABLE SYRINGES

K030683 · FMF

Nipro Medical Corp.

General Hospital · 240d

Cleared Oct 31, 2003

MERCATOR HEALTHCARE MALE LATEX CONDOM

K031369 · HIS

Mercator Healthcare , Ltd.

Obstetrics & Gynecology · 184d

Cleared Oct 31, 2003

JABES ELECTRONIC STETHOSCOPE

K031446 · DQD

Gs Technology Co., Ltd.

Cardiovascular · 177d

Cleared Oct 31, 2003

SPINERX-LDM

K031862 · ITH

Spinerx Technology

Physical Medicine · 137d

Cleared Oct 31, 2003

CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD

K031963 · KWA

Wrightmedicaltechnologyinc

Orthopedic · 128d

Cleared Oct 31, 2003

AUDICOR UPGRADE SYSTEM

K032145 · DPS

Inovise Medical, Inc.

Cardiovascular · 109d

Cleared Oct 31, 2003

ZOLL M SERIES NIBP OPTION

K032363 · DXN

Zoll Medical Corp

Cardiovascular · 92d

Cleared Oct 31, 2003

BONE CEMENT RADIO-OPACIFIER

K032388 · MYU

Cardinalhealth

Neurology · 88d

Cleared Oct 31, 2003

PLUS PIVOT LINK UNIVERSAL SYSTEM

K032398 · MNI

Spine Vision, Inc.

Orthopedic · 88d

Cleared Oct 31, 2003

GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET

K032426 · DTK

Cook, Inc.

Cardiovascular · 86d

Cleared Oct 31, 2003

HEDROCEL VERTEBRAL BODY REPLACEMENT

K032527 · MQP

Implex Corp.

Orthopedic · 77d

Cleared Oct 31, 2003

DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111

K032564 · LAN

Dade Behring, Inc.

Chemistry · 72d

Cleared Oct 31, 2003

DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110

K032573 · LAR

Dade Behring, Inc.

Chemistry · 72d

Cleared Oct 31, 2003

VITEK GRAM NEGATIVE GATIFLOXACIN

K032711 · LON

bioMerieux, Inc.

Microbiology · 59d

Cleared Oct 31, 2003

VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN

K032738 · LON

bioMerieux, Inc.

Microbiology · 57d

Cleared Oct 31, 2003

VITEK 2 GRAM POSITIVE LINEZOLID

K032766 · LON

bioMerieux, Inc.

Microbiology · 56d

Cleared Oct 31, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS

K032993 · JJX

Ortho-Clinical Diagnostics, Inc.

Microbiology · 36d

Cleared Oct 31, 2003

MODIFICATION TO GLOBALCARDIO

K033037 · DSH

Cardiocomm Solutions, Inc.

Cardiovascular · 32d

Cleared Oct 31, 2003

IONOFIL COLOR AC

K033068 · EMA

Voco GmbH

Dental · 32d

Cleared Oct 31, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS

K033127 · JJX

Ortho-Clinical Diagnostics

Microbiology · 31d