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

Cleared Jul 15, 2003

DBC PRESS ACUPUNCTURE NEEDLES

K031250 · MQX

Lhasa Medical, Inc.

General Hospital · 87d

Cleared Jul 15, 2003

AMERITEK SURE-POINT HDR NEEDLE TEMPLATE

K031273 · JAQ

Amertek Medical, Inc.

Radiology · 84d

Cleared Jul 15, 2003

FABIUS TIRO ANESTHESIA SYSTEM

K031400 · BSZ

Draeger Medical, Inc.

Anesthesiology · 71d

Cleared Jul 15, 2003

CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF

K031416 · DXQ

Clearmedical, Inc.

Cardiovascular · 71d

Cleared Jul 15, 2003

VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238

K031844 · LJT

Boston Scientific Corp

General Hospital · 29d

Cleared Jul 15, 2003

SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT

K031870 · LEG

Beckman Coulter, Inc.

Toxicology · 28d

Cleared Jul 14, 2003

INJECTOR

K023737 · MSS

Anton Meyer & Co. , Ltd.

Ophthalmic · 249d

Cleared Jul 14, 2003

SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J

K024007 · FOZ

Sunder Biomedical Tech. Co., Ltd.

General Hospital · 222d

Cleared Jul 14, 2003

ULTRAFLEX PRECISION COLONIC STENT

K030769 · MQR

Boston Scientific Corp

Gastroenterology & Urology · 125d

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