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

Cleared Oct 17, 2003

ROCHE DIAGNOSTICS OMNI S ANALYZER

K032311 · CEM

Roche Diagnostics Corp.

Chemistry · 81d

Cleared Oct 17, 2003

PROPHY-MATE

K032395 · EFB

Nakanishi, Inc.

Dental · 74d

Cleared Oct 17, 2003

MAXTER STERILE POWDER FREE SURGICAL GLOVES

K032501 · KGO

Maxter Glove Manufacturing Sdn Bhd

General Hospital · 65d

Cleared Oct 17, 2003

SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES

K032745 · LYZ

Shanghai Giantmax Plastic Product Corp.

General Hospital · 43d

Cleared Oct 17, 2003

SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES

K032746 · LYZ

Shanghai Giantmax Plastic Product Corp.

General Hospital · 43d

Cleared Oct 17, 2003

MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR

K032801 · JOJ

Albert Browne , Ltd.

General Hospital · 38d

Cleared Oct 17, 2003

MICROGENICS CYCLOSPORINE CONTROL KIT

K032842 · LAS

Microgenics Corp.

Chemistry · 36d

Cleared Oct 17, 2003

RADIUS COUGAR WIRE

K032899 · DQX

Radius Medical Technologies, Inc.

Cardiovascular · 30d

Cleared Oct 17, 2003

NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210

K032947 · DQA

Dolphin Medical, Inc.

Anesthesiology · 25d

Cleared Oct 16, 2003

MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND...

K030857 · EOB

Mahe Intl., Inc.

Ear, Nose, Throat · 212d

Cleared Oct 16, 2003

ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294

K031012 · FRC

3M Company

General Hospital · 199d

Cleared Oct 16, 2003

UUHC REPROCESSED COMPRESSION SLEEVE DEVICES

K031189 · JOW

University of Utah Hospitals and Clinics

Cardiovascular · 184d

Cleared Oct 16, 2003

STRYKER FLEXIBLE URETEROSCOPE

K031278 · FGB

Stryker Endoscopy

Gastroenterology & Urology · 177d

Cleared Oct 16, 2003

POWDER FREE LATEX EXAM GLOVES

K031335 · LYY

Tan Sin Lian Industries Sdn. Bhd.

General Hospital · 171d

Cleared Oct 16, 2003

EASYGLUCO, MODEL IGM0002

K031501 · NBW

American Healthcare, Inc.

Chemistry · 156d

Cleared Oct 16, 2003

ENK FIBEROPTIC ATOMIZER SET

K031966 · EOQ

Cook, Inc.

Ear, Nose, Throat · 112d

Cleared Oct 16, 2003

LTV-1000 VENTILATOR

K032226 · CBK

Pulmonetic Systems, Inc.

Anesthesiology · 87d

Cleared Oct 16, 2003

MODEL IR 1200 INSULIN PUMP

K032257 · LZG

Animas Corp.

General Hospital · 86d

Cleared Oct 16, 2003

VISTAKON (GALYFILCON A) SOFT CONTACT LENS

K032340 · LPL

Johnson & Johnson Vision Care, Inc.

Ophthalmic · 79d

Cleared Oct 16, 2003

MAGNETOM AVANTO MR SYSTEM

K032428 · LNH

Siemens Medical Solutions USA, Inc.

Radiology · 79d

Cleared Oct 16, 2003

PROWESS

K032456 · MUJ

Prowess, Inc.

Radiology · 66d

Cleared Oct 16, 2003

AUTOSET SPIRIT SYSTEM

K032480 · BZD

Resmed, Ltd.

Anesthesiology · 65d

Cleared Oct 16, 2003

INTELEPACS

K032533 · LLZ

Intelerad Medical Systems, Inc.

Radiology · 62d

Cleared Oct 16, 2003

HOLOGIC DR IMAGEPRO

K032546 · LLZ

Hologic, Inc.

Radiology · 59d