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

Cleared Jan 07, 2003

ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650

K023840 · CKB

Bayer Diagnostics Corp.

Chemistry · 50d

Cleared Jan 07, 2003

OBC-250-PAN BREAST ARRAY COIL

K024208 · MOS

Mri Devices Corp.

Radiology · 18d

Cleared Jan 06, 2003

CUSTODIOL HTK SOLUTION

K020924 · KDL

Dr. Franz Kohler Chemie GmbH

Gastroenterology & Urology · 291d

Cleared Jan 06, 2003

VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110

K023410 · JJY

Maine Standards Co.

Chemistry · 88d

Cleared Jan 06, 2003

SERAQUEST ANTI-THYROGLOBULIN

K023592 · DDC

Quest Intl., Inc.

Immunology · 73d

Cleared Jan 06, 2003

MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

K024048 · FGE

Boston Scientific Scimed, Inc.

Gastroenterology & Urology · 28d

Cleared Jan 06, 2003

SHANGHAI HUAMAO POWDER-FREE YELLOW VINYL EXAM GLOVES

K024154 · LYZ

Shanghai Huamao Gloves Co., Ltd.

General Hospital · 20d

Cleared Jan 06, 2003

NIM-PRS

K024316 · IKN

Medtronic Xomed, Inc.

Neurology · 11d

Cleared Jan 03, 2003

CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM

K022126 · HAW

Medtronic Surgical Navigation...

Neurology · 186d

Cleared Jan 03, 2003

BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON

K022521 · KPO

Rockwell Medical Technologies, Inc.

Gastroenterology & Urology · 157d

Cleared Jan 03, 2003

IMAGE3 SE DISPOSABLE FULL FACE MASK

K023135 · CBK

Respironics, Inc.

Anesthesiology · 105d

Cleared Jan 03, 2003

TROPHYPAN

K023346 · MUH

Trophy Radiologie

Radiology · 88d

Cleared Jan 03, 2003

USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8

K023358 · FGB

Acmi Corporation

Gastroenterology & Urology · 88d

Cleared Jan 03, 2003

ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101

K023373 · IYX

Gvi Technology Partners

Radiology · 87d

Cleared Jan 03, 2003

IMMUNOCARD STAT! E. COLI O157 PLUS

K023599 · GMZ

Meridian Bioscience, Inc.

Microbiology · 67d

Cleared Jan 03, 2003

CASSETTE/URINE HCG

K023638 · LCX

Ind Diagnostic, Inc.

Chemistry · 65d

Cleared Jan 03, 2003

WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354

K023744 · JHW

Wiener Laboratories Saic

Chemistry · 57d

Cleared Jan 03, 2003

PENTRA 80

K024002 · GKZ

Abx Diagnostics

Hematology · 30d

Cleared Jan 03, 2003

MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT

K024195 · MID

Corgenix, Inc.

Immunology · 14d

Cleared Jan 03, 2003

REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT

K024196 · MID

Corgenix, Inc.

Immunology · 14d

Cleared Jan 03, 2003

LIFEDOP DOPPLER

K024197 · KNG

Summit Doppler Systems, Inc.

Radiology · 14d

Cleared Jan 02, 2003

COSMED MICROQUARK

K020745 · BTY

Cosmed Srl

Anesthesiology · 301d

Cleared Jan 02, 2003

REEVUE INDIRECT CALORIMETER, MODEL#8100

K021490 · BZL

Korr Medical Technologies, Inc.

Anesthesiology · 238d

Cleared Jan 02, 2003

BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM

K021994 · FGE

C.R. Bard, Inc.

Gastroenterology & Urology · 198d