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

Cleared Sep 05, 2003

ACUEITY MEDICAL LIGHT SOURCE

K032430 · FCW

Acueity, Inc.

Gastroenterology & Urology · 30d

Cleared Sep 05, 2003

PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER

K032494 · KRA

Precision Vascular Systems, Inc.

Cardiovascular · 23d

Cleared Sep 05, 2003

INTERLOK BIO-MODULAR HUMERAL STEMS

K032507 · KWT

Biomet, Inc.

Orthopedic · 22d

Cleared Sep 05, 2003

ENCLOSE II ANASTOMOSIS ASSIST DEVICE

K032589 · DXC

Novare Surgical Systems, Inc.

Cardiovascular · 14d

Cleared Sep 05, 2003

ONE DIMENSIONAL WATER PHANTOM, WP 1D

K032594 · IYE

Wellhofer Dosimetrie

Radiology · 14d

Cleared Sep 04, 2003

DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER

K030629 · DQA

Dolphin Medical, Inc.

Anesthesiology · 189d

Cleared Sep 04, 2003

TMC ELECTRICAL SCOOTER, EASY 405

K031313 · INI

Tmc Technology Corp.

Physical Medicine · 133d

Cleared Sep 04, 2003

TMC ELECTRICAL SCOOTER, EASY 411

K031314 · INI

Tmc Technology Corp.

Physical Medicine · 133d

Cleared Sep 04, 2003

TMC ELECTRICAL SCOOTER, EASY 321

K031315 · INI

Tmc Technology Corp.

Physical Medicine · 133d

Cleared Sep 04, 2003

MACROPORE CARDIO-WRAP (TS)

K031785 · OMH

Macropore Biosurgery, Inc.

Cardiovascular · 86d

Cleared Sep 04, 2003

PIT & FISSURE SEALANT WITH FLUORIDE

K031811 · EBC

Harry J. Bosworth Co.

Dental · 84d

Cleared Sep 04, 2003

ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY

K031857 · DEM

Bayer Diagnostics Corp.

Chemistry · 80d

Cleared Sep 04, 2003

EBI XFIX DFS SYSTEM

K031919 · KTT

Ebi, L.P.

Orthopedic · 73d

Cleared Sep 04, 2003

ALANTECH GRAFT FIXATION SCREW

K031937 · HWC

Arthrocare Corp.

Orthopedic · 73d

Cleared Sep 04, 2003

SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES

K032032 · HRS

Synthes (Usa)

Orthopedic · 65d

Cleared Sep 04, 2003

CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)

K032037 · MNI

Medtronic Sofamor Danek

Orthopedic · 65d

Cleared Sep 04, 2003

WIROBOND C

K032136 · EJH

Bego U.S.A.

Dental · 55d

Cleared Sep 04, 2003

MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K032457 · FGE

Cordis Corp.

Gastroenterology & Urology · 24d

Cleared Sep 04, 2003

HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS

K032479 · JWH

Howmedica Osteonics Corp.

Orthopedic · 23d

Cleared Sep 04, 2003

ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR

K032491 · DSB

Imagyn Medical Technologies, Inc.

Cardiovascular · 23d

Cleared Sep 04, 2003

ALEXANDER

K032493 · EJT

Ivoclar Vivadent, Inc.

Dental · 23d

Cleared Sep 03, 2003

EDWARDS DIRECTIONAL CATHETER

K030630 · DQY

Edwards Lifesciences, LLC

Cardiovascular · 188d

Cleared Sep 03, 2003

MEDRO SPD

K030652 · FIP

Usfilter/Ionpure, Inc.

Gastroenterology & Urology · 187d

Cleared Sep 03, 2003

PATHWAY ACCESS SHEATH CATHETER

K030662 · EZN

Vertelink Corporation

Gastroenterology & Urology · 184d