FDA 510(k) Searchable Database - Search 174,000+ Clearances

Cleared Jul 14, 2003

VERDICT II, PROFILE II

K031032 · DJG

Medtox Diagnostics, Inc.

Toxicology · 104d

Cleared Jul 14, 2003

PCW PERCUTANEOUS COMPRESSION WIRE

K031050 · HWC

Millennium Medical Technologies, Inc.

Orthopedic · 103d

Cleared Jul 14, 2003

FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS

K031067 · HEB

First Quality Hygienic, Inc.

Obstetrics & Gynecology · 101d

Cleared Jul 14, 2003

EXTERNAL FIXATION SYSTEMS

K031181 · KTT

Smith & Nephew, Inc.

Orthopedic · 90d

Cleared Jul 14, 2003

TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE

K031183 · JWH

Centerpulse Orthopedics, Inc.

Orthopedic · 90d

Cleared Jul 14, 2003

BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST

K031203 · JWJ

DePuy Orthopaedics, Inc.

Orthopedic · 89d

Cleared Jul 14, 2003

SYNTHES SMALL COBINATION CLAMP-MR SAFE

K031724 · KTT

Synthes (Usa)

Orthopedic · 41d

Cleared Jul 14, 2003

BACT/ALERT MP CULTURE BOTTLES (PLASTIC)

K031737 · MDB

bioMerieux, Inc.

Microbiology · 40d

Cleared Jul 14, 2003

ACON STREP A RAPID TEST DEVICE

K031784 · GTY

ACON Laboratories, Inc.

Microbiology · 34d

Cleared Jul 14, 2003

VAXCEL WITH PASV PORT, MODEL 45-213

K032008 · LJT

Boston Scientific Corp

General Hospital · 14d

Cleared Jul 12, 2003

KAMAR ANNULUS DILATOR + SIZER

K030788 · DWP

Geister Medizin Technik GmbH

Cardiovascular · 122d

Cleared Jul 12, 2003

SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE

K031914 · MQP

Spinal Concepts, Inc.

Orthopedic · 22d

Cleared Jul 11, 2003

BUTLER GUM PROPHY PASTE WITH NOVAMIN

K024343 · EJR

Usbiomaterials Corp.

Dental · 196d

Cleared Jul 11, 2003

VASC-ALERT

K030456 · KOC

Vasc-Alert, LLC

Gastroenterology & Urology · 150d

Cleared Jul 11, 2003

MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE

K030547 · DRL

Guardian Angel Products, Inc.

Cardiovascular · 141d

Cleared Jul 11, 2003

AUTION JET AJ-4270 URINE ANALYZER

K030600 · KQO

International Remote Imaging Systems

Chemistry · 136d

Cleared Jul 11, 2003

TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD...

K030703 · NBW

Home Diagnostics, Inc.

Chemistry · 127d

Cleared Jul 11, 2003

A/C ENZYMATIC HOMOCYSTEINE ASSAY

K030754 · LPS

Anticancer, Inc.

Toxicology · 123d

Cleared Jul 11, 2003

COOK GASTRIC SIZING BALLOON CATHETER

K030841 · KNT

Cook, Inc.

Gastroenterology & Urology · 116d

Cleared Jul 11, 2003

C. DIFF CHEK - 30

K030991 · LLH

Techlab, Inc.

Microbiology · 105d

Cleared Jul 11, 2003

C. DIFF CHEK - 60

K030992 · LLH

Techlab, Inc.

Microbiology · 105d

Cleared Jul 11, 2003

NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES

K031060 · MQX

Lhasa Medical, Inc.

General Hospital · 99d

Cleared Jul 11, 2003

TEMPORARY RESIN CEMENT

K031212 · EMA

Parkell, Inc.

Dental · 85d

Cleared Jul 11, 2003

OPTIBOLUS

K031339 · DXT

Mallinckrodt Inc., Liebel-Flarsheim...

Cardiovascular · 74d