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

Cleared Dec 24, 2003

PORTASCAN BLADDER SCANNER, MODEL PA00146

K033906 · IYO

Mediwatch Plc

Radiology · 7d

Cleared Dec 23, 2003

RANDOX EVIDENCE

K030360 · DIO

Randox Laboratories, Ltd.

Chemistry · 323d

Cleared Dec 23, 2003

STERICHEK BICARB PH REAGENT STRIPS

K031267 · MNV

Environmental Test Systems, Inc.

Gastroenterology & Urology · 246d

Cleared Dec 23, 2003

ERGO SRS

K031281 · MUJ

3D Line USA, Inc.

Radiology · 245d

Cleared Dec 23, 2003

INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS

K031322 · DZE

Intra-Lock International

Dental · 242d

Cleared Dec 23, 2003

DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

K031689 · NQJ

Chf Solutions, Inc.

Gastroenterology & Urology · 204d

Cleared Dec 23, 2003

DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH,...

K032061 · MSD

Spire Biomedical, Inc.

Gastroenterology & Urology · 173d

Cleared Dec 23, 2003

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

K032113 · NOT

Chroma Vision Medical Systems, Inc.

Pathology · 167d

Cleared Dec 23, 2003

HEPARIN LOCK FLUSH SYRINGE

K032417 · FOZ

Am2 Pat, Inc.

General Hospital · 140d

Cleared Dec 23, 2003

CLINITEST HCG PREGNANCY TEST

K032563 · JHI

Bayer Healthcare, LLC

Chemistry · 125d

Cleared Dec 23, 2003

INTERMITTENT URETHRAL CATHETERS

K033023 · KOD

Rusch Intl.

Gastroenterology & Urology · 88d

Cleared Dec 23, 2003

DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST

K033045 · EJH

American Green Dent. Mfg, Inc.

Dental · 85d

Cleared Dec 23, 2003

SUBTALAR PEG IMPLANT

K033046 · MJW

Nexa Orthopedics, Inc.

Orthopedic · 85d

Cleared Dec 23, 2003

UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC,...

K033113 · HIH

Richard Wolf Medical Instruments Corp.

Obstetrics & Gynecology · 84d

Cleared Dec 23, 2003

TRILOGY RADIOTHERAPY DELIVERY SYSTEM

K033343 · IYE

Varian Medical Systems, Inc.

Radiology · 67d

Cleared Dec 23, 2003

DIAZYME LITHIUM ENZYMATIC ASSAY KIT

K033360 · JII

General Atomics

Chemistry · 63d

Cleared Dec 23, 2003

TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG...

K033383 · NBC

Biosite Incorporated

Chemistry · 61d

Cleared Dec 23, 2003

LONG LOVE CONDOM

K033541 · HIS

Unidus Corp.

Obstetrics & Gynecology · 43d

Cleared Dec 23, 2003

IRRIGATION CHANNEL TUBING, MODEL 100135

K033695 · OCX

Byrne Medical, Inc.

Gastroenterology & Urology · 28d

Cleared Dec 23, 2003

MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1

K033712 · LLZ

Sectra-Imtec AB

Radiology · 27d

Cleared Dec 23, 2003

SYNGO PERFUSION-CT

K033832 · JAK

Siemens AG Medical Solutions

Radiology · 13d

Cleared Dec 23, 2003

A1CNOW FOR HOME AND PROFESSIONAL USE

K033847 · LCP

Metrika, Inc.

Chemistry · 12d

Cleared Dec 22, 2003

FIDJI SMALL CEMENT RESTRICTOR

K030767 · JDK

Spine Next SA

Orthopedic · 286d

Cleared Dec 22, 2003

FIDJI LARGE CEMENT RESTRICTOR

K030871 · JDK

Spine Next SA

Orthopedic · 278d