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

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

Cleared Jul 11, 2003

PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL

K031366 · MOS

Usa Instruments, Inc.

Radiology · 72d

Cleared Jul 11, 2003

ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1

K031417 · DQY

Intra Luminal Therapeutics, Inc.

Cardiovascular · 67d

Cleared Jul 11, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE

K031589 · LON

Becton, Dickinson & CO

Microbiology · 51d

Cleared Jul 11, 2003

MODIFICATION TO HERMES O.R. CONTROL CENTER

K031720 · GCJ

Computer Motion, Inc.

General & Plastic Surgery · 38d

Cleared Jul 11, 2003

MEDRAD SWABBABLE VALVE TRANSFER SET

K031808 · FPK

Medrad, Inc.

General Hospital · 29d

Cleared Jul 11, 2003

HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1

K031823 · MQP

Implex Corp.

Orthopedic · 28d

Cleared Jul 11, 2003

GEMINI 16

K032036 · KPS

Philips Medical Systems (Cleveland),...

Radiology · 10d

Cleared Jul 10, 2003

COACH 888W

K030760 · ITI

Wheelchair & Scooter Express

Physical Medicine · 121d

Cleared Jul 10, 2003

4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX,...

K030852 · DRF

Mogul Enterprises

Cardiovascular · 114d

Cleared Jul 10, 2003

GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S...

K031036 · MLY

Gebauer Co.

Physical Medicine · 100d

Cleared Jul 10, 2003

AEROLET TOILET LIFT, MODEL AER-01

K031045 · INO

Economic Holland B.V.

Physical Medicine · 71d

Cleared Jul 10, 2003

IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96

K031059 · MHJ

Ivd Research, Inc.

Microbiology · 104d

Cleared Jul 10, 2003

EBI XFIX OPTIROM KNEE FIXATOR

K031093 · KTT

Ebi, L.P.

Orthopedic · 94d

Cleared Jul 10, 2003

RH-900

K031115 · KTB

Iomed, Inc.

Physical Medicine · 93d

Cleared Jul 10, 2003

BODY SIGNAL ECG ELECTRODE

K031174 · DRX

Wandy Rubber Industrial Co., Ltd.

Cardiovascular · 87d