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

Cleared Sep 25, 2003

PRECISE CARBON FIBER TABLE TOP, MODEL 11-999

K032248 · IYE

Aktina Medical Physics Corp.

Radiology · 65d

Cleared Sep 25, 2003

ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105...

K032355 · EHD

Dentsply Gendex

Radiology · 57d

Cleared Sep 25, 2003

SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT

K032497 · HCG

Micro Therapeutics, Inc.

Neurology · 43d

Cleared Sep 25, 2003

EXOMIO, MODEL 2.0 SP1

K032550 · KPQ

Medcom GmbH

Radiology · 38d

Cleared Sep 25, 2003

NUMED TYSHAK MINI PEDIATRIC PTV CATHETER

K032591 · DQY

NuMED, Inc.

Cardiovascular · 34d

Cleared Sep 25, 2003

HRK-63-8 KNEE ARRAY COIL

K032633 · MOS

Mri Devices Corp.

Radiology · 30d

Cleared Sep 24, 2003

REPROCESSED ELECTROPHYSIOLOGY CATHETER

K030187 · NLH

Alliance Medical, Inc.

Cardiovascular · 246d

Cleared Sep 24, 2003

HEMAPROMPT GASTRIC

K031356 · KHE

Aerscher Diagnostics

Hematology · 166d

Cleared Sep 24, 2003

GI SUPPLY BILIARY STENT

K031360 · FGE

Gi Supply

Gastroenterology & Urology · 147d

Cleared Sep 24, 2003

EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM

K031898 · GKR

Ekf Diagnostic GmbH

Hematology · 97d

Cleared Sep 24, 2003

GLOBAL CAP RESURFACING REPLACEMENT SHOULDER

K031971 · HSD

DePuy Orthopaedics, Inc.

Orthopedic · 90d

Cleared Sep 24, 2003

TELEMIS-MEDICAL SOLUTION

K032157 · LLZ

Telemis S.A.

Radiology · 72d

Cleared Sep 24, 2003

JUSTWIN SCOOTER, MODEL JS-401

K032277 · INI

Joy Ride Tech Co., Ltd.

Physical Medicine · 63d

Cleared Sep 24, 2003

RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,

K032402 · IOR

Convaid Products, Inc.

Physical Medicine · 51d

Cleared Sep 24, 2003

WU'S 4-WHEELED NEO SCOOTER, WT-M4JR

K032489 · INI

Wu'S Tech Co., Ltd.

Physical Medicine · 43d

Cleared Sep 24, 2003

AIR PRESS MASSAGER

K032505 · IRP

Telebrands Corp

Physical Medicine · 42d

Cleared Sep 24, 2003

DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300

K032635 · LMC

Agfa Corp.

Radiology · 29d

Cleared Sep 24, 2003

MODIFICATION TO: AURORA

K032678 · LNH

Aurora Imaging Technology, Inc.

Radiology · 26d

Cleared Sep 24, 2003

KONICA LASER IMAGER, MODEL DRYPRO MODEL 771

K032681 · LMC

Konica Medical and Graphic Corporation

Radiology · 26d

Cleared Sep 24, 2003

INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC

K032780 · MEG

Inviro Medical

General Hospital · 16d

Cleared Sep 23, 2003

ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)

K023429 · MNW

Rowenta, Inc.

Gastroenterology & Urology · 347d

Cleared Sep 23, 2003

PALACOS R

K030902 · LOD

Heraeus Kulzer GmbH & Co. KG

Orthopedic · 183d

Cleared Sep 23, 2003

OSTEOPAL

K030903 · LOD

Heraeus Kulzer GmbH & Co. KG

Orthopedic · 183d

Cleared Sep 23, 2003

PALAMED

K030904 · LOD

Heraeus Medical GmbH Technology

Orthopedic · 183d