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

Cleared May 02, 2003

ACCESS OV MONITOR ASSAY

K031297 · LTK

Beckman Coulter, Inc.

Immunology · 8d

Cleared May 01, 2003

SMALL VOLUME NEBULIZER

K023602 · CAF

Allegiance Healthcare Corporation

Anesthesiology · 185d

Cleared May 01, 2003

SUNPEX TECHNOLOGIES MODEL PW

K024175 · ITI

Sunpex Technology Co., Ltd.

Physical Medicine · 134d

Cleared May 01, 2003

CHUMP

K030017 · IOR

Colours 'N Motion

Physical Medicine · 119d

Cleared May 01, 2003

IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR

K030432 · ITI

Imc-Heart Way LLC

Physical Medicine · 80d

Cleared May 01, 2003

STRATUSOCT WITH RNFL NORMATIVE DATABASE

K030433 · HLI

Carl Zeiss Meditec, Inc.

Ophthalmic · 80d

Cleared May 01, 2003

MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES

K030733 · LPH

Zimmer, Inc.

Orthopedic · 52d

Cleared May 01, 2003

AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA

K030741 · MID

Hycor Biomedical , Ltd.

Immunology · 52d

Cleared May 01, 2003

LITTLE COACH

K030759 · INI

Wheelchair & Scooter Express

Physical Medicine · 51d

Cleared May 01, 2003

PASCO MIC AND MIC/ID PANELS

K030933 · JWY

Pasco Laboratories, Inc.

Microbiology · 37d

Cleared May 01, 2003

SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM

K031162 · JDQ

Smith & Nephew, Inc.

Orthopedic · 17d

Cleared May 01, 2003

MEDIPALM-20

K031202 · OLV

Braebon Medical Corp.

Neurology · 15d

Cleared Apr 30, 2003

HEMO-STREAM HEMODIALYSIS CATHETER SET

K023847 · MSD

Rex Medical

Gastroenterology & Urology · 162d

Cleared Apr 30, 2003

'RAPIDTEC'-5M-MULTIPLE DIP TEST

K023869 · DJR

American Bio Medica Corp.

Toxicology · 161d

Cleared Apr 30, 2003

ATHENA PELVIC MUSCLE TRAINER

K023905 · KPI

Athena Feminine Technologies, Inc.

Gastroenterology & Urology · 159d

Cleared Apr 30, 2003

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT

K030415 · LJS

AngioDynamics, Inc.

General Hospital · 82d

Cleared Apr 30, 2003

CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE

K030451 · FBK

Carbon Medical Technologies, Inc.

Gastroenterology & Urology · 78d

Cleared Apr 30, 2003

CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS

K030690 · LMC

Codonics, Inc.

Radiology · 56d

Cleared Apr 30, 2003

ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE

K031185 · FRN

Abbott Laboratories

General Hospital · 15d

Cleared Apr 30, 2003

AQUASENS FLUID MONITORING SYSTEM

K031213 · HIG

Davol, Inc.

Obstetrics & Gynecology · 13d

Cleared Apr 29, 2003

GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

K020418 · MEA

P.T. Greenleaf

General Hospital · 446d

Cleared Apr 29, 2003

GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

K020421 · MEA

Hennig Enterprises Europe Srl

General Hospital · 446d

Cleared Apr 29, 2003

CARBODISSECTING ENDOSCOPE

K020925 · DWX

Endo Surgical Devices, Inc.

Cardiovascular · 404d

Cleared Apr 29, 2003

ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR

K021174 · DSB

Imagyn Surgical

Cardiovascular · 382d