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

Cleared May 06, 2003

EK-PRO ARRHYTHMIA DETECTION ALGORITHM

K031320 · MHX

Ge Medical Systems Information...

Cardiovascular · 11d

Cleared May 05, 2003

BIOMET CRANIOFACIAL ACRYLIC CEMENT

K011399 · GXP

Biomet, Inc.

Neurology · 728d

Cleared May 05, 2003

ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800

K023230 · IPF

Western Clinical Technology Systems,...

Physical Medicine · 220d

Cleared May 05, 2003

ADHOC CLAW

K023963 · MBI

Future Medical Systems, Inc.

Orthopedic · 157d

Cleared May 05, 2003

PRIMA III TOTALSENSE TORSO COIL

K030371 · MOS

Usa Instruments, Inc.

Radiology · 90d

Cleared May 05, 2003

SOFT-TOUCH TENS ELECTRODE

K030375 · GXY

Pain Management Technologies

Neurology · 90d

Cleared May 05, 2003

POLY PER-Q-CATH PICC CATHETERS

K031129 · LJS

C.R. Bard, Inc.

General Hospital · 26d

Cleared May 05, 2003

SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES

K031178 · HRS

Synthes (Usa)

Orthopedic · 21d

Cleared May 05, 2003

CDR PANX, MODEL 4792

K031291 · MUH

Schick Technologies, Inc.

Radiology · 12d

Cleared May 02, 2003

HIVOX DREAMATE DM-800

K021952 · GZJ

Hivox Biotek, Inc.

Neurology · 323d

Cleared May 02, 2003

CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION

K023286 · DXN

Neptec Design Group, Ltd.

Cardiovascular · 212d

Cleared May 02, 2003

GLYCA-DIRECT FRUCTOSAMINE

K023654 · LCP

Polymedco, Inc.

Chemistry · 184d

Cleared May 02, 2003

AIRLIFE DEMAND NASAL CANNULA

K023673 · NFB

Allegiance Healthcare Corp.

Anesthesiology · 182d

Cleared May 02, 2003

BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION

K024289 · MRC

Bausch & Lomb, Incorporated

Ophthalmic · 130d

Cleared May 02, 2003

REPROCESSED ELECTROPHYSIOLOGY CATHETER

K030026 · NLH

Alliance Medical Corp.

Cardiovascular · 119d

Cleared May 02, 2003

NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735

K030207 · LZA

Shanghai Motex Healthcare Co., Ltd.

General Hospital · 101d

Cleared May 02, 2003

DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING...

K030343 · HAW

Gyrus Ent LLC

Neurology · 88d

Cleared May 02, 2003

TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

K030346 · LNS

Fmd, LLC

Gastroenterology & Urology · 88d

Cleared May 02, 2003

20.1 MONOCHROME LCD MONITOR, RADIFORCE G20

K030347 · LLZ

Eizo Nanao Corporation

Radiology · 88d

Cleared May 02, 2003

HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945...

K030349 · MNW

Bonso Electronics International, Inc.

Gastroenterology & Urology · 88d

Cleared May 02, 2003

FLUORILAQ

K030488 · LBH

Pascal Co., Inc.

Dental · 77d

Cleared May 02, 2003

BRM2 BRAIN MONITOR

K030489 · OLT

Brainz Instruments , Ltd.

Neurology · 77d

Cleared May 02, 2003

HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS

K030515 · CBK

Hans Rudolph, Inc.

Anesthesiology · 72d

Cleared May 02, 2003

KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE...

K030607 · EIH

Kavo America

Dental · 65d