Transducer, Ultrasonic, Diagnostic

FDA product code ITX · 410 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1570
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-05-09 – 2026-09-24

ITX 2007-10-29

MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00

Applicant Toshibamedical Systems Corporation

K number K072918

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ITX 2007-10-24

APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Toshiba America Medical Systems, In.C

K number K072826

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ITX 2007-10-15

BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B

Applicant Broadsound Corporation

K number K070195

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ITX 2007-09-25

SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM

Applicant Senorx, Inc.

K number K072541

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ITX 2007-09-05

DC-6 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K072164

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ITX 2007-08-30

ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM

Applicant Aloka Co., Ltd.

K number K072285

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ITX 2007-08-29

ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K072266

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ITX 2007-07-30

A-VIEW BASIC AND PLUS

Applicant Cordatec N.V.

K number K070515

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ITX 2007-07-02

MYLAB40

Applicant Esaote Europe B.V.

K number K070903

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ITX 2006-10-27

GYNESONICS EC6 TRANSDUCER

Applicant Gynesonics, Inc.

K number K061153

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ITX 2006-08-18

SONOMARK

Applicant Medical Products Manufacturing, Inc.

K number K061560

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ITX 2006-04-19

SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020

Applicant Boston Scientific Corp

K number K060947

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ITX 2006-04-19

MODEL EC9-4 TRANSDUCER

Applicant Siemens Medical Solutions USA, Inc.

K number K060879

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ITX 2006-03-07

AIM ACCURACY IN MARKING SYSTEM

Applicant Georgene Austria

K number K053463

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ITX 2005-09-29

SITE-RITE 5 ULTRASOUND SYSTEM

Applicant C.R. Bard, Inc.

K number K052517

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ITX 2005-08-17

V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER

Applicant Siemens Medical Solutions USA, Inc.

K number K052021

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ITX 2005-08-15

FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT

Applicant Ascendia Medtech AB

K number K050320

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ITX 2005-04-18

SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM

Applicant C.R. Bard, Inc.

K number K050724

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ITX 2005-02-28

SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)

Applicant Sheathing Technologies, Inc.

K number K043425

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ITX 2004-12-13

TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES

Applicant Teratech Corp.

K number K043278

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ITX 2004-11-18

IOP8 INTRA OPERATIVE PROBE

Applicant Huntleigh Healthcare, Inc.

K number K032315

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ITX 2004-11-10

SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020

Applicant Boston Scientific Corp

K number K041818

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ITX 2004-10-19

SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT

Applicant Bard Access Systems, Inc.

K number K042445

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ITX 2004-09-22

MHLX7EC TRANSDUCER

Applicant Microhelix, Inc.

K number K040213

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ITX 2004-09-02

TARGETSCAN BIOPSY KIT

Applicant Envisioneering, LLC

K number K041638

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ITX 2004-09-01

TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM

Applicant Envisioneering, LLC

K number K041637

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ITX 2004-06-09

EG-3830UT

Applicant Pentax Precision Instrument Corp.

K number K041397

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ITX 2004-06-09

FG-36UX FIBER ULTRASOUND GASTROSCOPE

Applicant Pentax Precision Instrument Corp.

K number K041396

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ITX 2004-06-09

EG-3630UR

Applicant Pentax Precision Instrument Corp.

K number K041395

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ITX 2004-04-14

TERATECH MODEL 10V5 SMART PROBE

Applicant Teratech Corp.

K number K040840

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ITX 2003-09-11

LATEX ULTRASONIC PROBE COVER

Applicant Pleasure Latex Products Sdn. Bhd.

K number K022156

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ITX 2003-07-23

CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001

Applicant Trans Vascular Incorporated

K number K031920

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ITX 2003-05-20

AMERITEK SURE-POINT TRACKER SYSTEM

Applicant Amertek Medical, Inc.

K number K030518

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ITX 2003-05-09

TRANSVAGINAL DOPPLER PROBE

Applicant Vascular Control Systems, Inc.

K number K031358

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ITX 2003-01-22

ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY

Applicant Sonosite,Inc.

K number K030064

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ITX 2002-11-21

ATLANTIS PV IMAGING CATHETER, MODEL 36456

Applicant Boston Scientific, Target

K number K022860

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ITX 2002-09-26

TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02

Applicant Vascular Control Systems, Inc.

K number K023024

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ITX 2002-09-06

COOK-SWARTZ DOPPLER FLOW PROBE

Applicant Cook Vascular, Inc.

K number K022649

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ITX 2002-04-02

CROSSPOINT TRANSACCESS CATHETER

Applicant Trans Vascular Incorporated

K number K013363

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ITX 2002-02-06

MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER

Applicant Hitachi Medical Corp.

K number K013723

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ITX 2002-01-03

TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS

Applicant Tetrad Corp.

K number K014182

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ITX 2001-12-28

SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER

Applicant CIVCO Medical Instruments Co., Inc.

K number K013721

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ITX 2001-12-18

SHAPEABLE DOPPLER FLOW PROBE

Applicant Cook Vascular, Inc.

K number K002958

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ITX 2001-12-03

TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS

Applicant Tetrad Corp.

K number K013849

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ITX 2001-11-13

SCANTAC MEMBRANE OR SCANTAC STRIP

Applicant Sonotech, Inc.

K number K013170

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ITX 2001-10-30

ULTRASOUND TRANSDUCER COVER

Applicant Advance Medical Designs, Inc.

K number K011265

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ITX 2001-10-18

WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL

Applicant National Therapy Products, Inc.

K number K012522

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ITX 2001-07-17

AMERITEK BRACHYTHERAPY TEMPLATE

Applicant Amertek Medical, Inc.

K number K011581

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ITX 2001-06-20

THIN FILM DRESSING FOR ULTRASOUND EXAM

Applicant Martin E. Wendelken

K number K011284

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ITX 2001-05-15

OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM

Applicant Aloka Co., Ltd.

K number K011314

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ITX 2001-05-04

TETRAD TC-C3-ACP

Applicant Tetrad Corp.

K number K002193

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ITX 2001-04-06

TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE

Applicant Teratech Corp.

K number K010883

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ITX 2001-04-02

AT3C70 TRANSDUCER

Applicant Sonora Medical Systems

K number K002856

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ITX 2000-09-20

ALOKA UST-5280-5

Applicant Aloka Co., Ltd.

K number K002784

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ITX 2000-09-05

OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT

Applicant Olympus America, Inc.

K number K994103

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ITX 2000-06-02

OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE

Applicant Olympus America, Inc.

K number K994106

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ITX 2000-06-02

OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE

Applicant Olympus America, Inc.

K number K994069

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ITX 2000-05-26

OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT

Applicant The Olympus Optical Co.

K number K001203

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ITX 2000-05-12

BALLOON FOR ULTRASONIC ENDOSCOPES

Applicant N.M. Beale Co., Inc.

K number K992178

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ITX 2000-04-24

GE LOGIQ 700

Applicant GE Medical Systems

K number K001016

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ITX 2000-03-24

HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4)

Applicant Atl Ultrasound, Inc.

K number K994373

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ITX 1999-09-08

MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004

Applicant Medi-Stim A/S

K number K992305

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ITX 1999-08-27

IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER

Applicant Jomed Imaging , Ltd.

K number K982208

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ITX 1999-08-17

GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF

Applicant CIVCO Medical Instruments Co., Inc.

K number K992152

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ITX 1999-07-12

THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER

Applicant Medison America, Inc.

K number K984639

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ITX 1999-07-08

VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7

Applicant Medison America, Inc.

K number K992155

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ITX 1999-06-08

VIVOSONIC

Applicant Sonotech, Inc.

K number K984562

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ITX 1999-06-02

GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER,

Applicant CIVCO Medical Instruments Co., Inc.

K number K991236

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ITX 1999-05-05

SCANFLEX SOLID COUPLANT MEMBRANE

Applicant Sonotech, Inc.

K number K983691

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ITX 1999-04-21

SHEATHES (NON-LATEX), STERILE

Applicant Sheathing Technologies, Inc.

K number K990175

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ITX 1999-02-25

HYBRISONIC SHEATH

Applicant Sonotech, Inc.

K number K983985

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ITX 1999-02-24

LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM

Applicant Hewlett-Packard Co.

K number K990400

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ITX 1999-01-25

BLADDERMANAGER PCI 5000 MODEL 1002

Applicant Diagnostic Ultrasound Corp.

K number K982568

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ITX 1999-01-14

VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)

Applicant Endosonics Corp.

K number K982329

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ITX 1998-12-11

OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE

Applicant Olympus America, Inc.

K number K982323

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ITX 1998-11-16

OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)

Applicant Olympus Optical, Co.

K number K982610

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ITX 1998-10-28

OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE

Applicant The Olympus Optical Co.

K number K982733

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ITX 1998-10-23

OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE

Applicant Olympus America, Inc.

K number K982725

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ITX 1998-09-23

ULTRA-COVER PU-TRANSDUCER COVER

Applicant International Medical Products B.V.

K number K981069

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ITX 1998-08-21

ULTRA IMAGE AND ULTRA SCAN

Applicant Sonotech, Inc.

K number K981028

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ITX 1998-07-27

EUP-OL334 LAPARASCOPICPROBE

Applicant Hitachi Medical Corp. of America

K number K981434

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ITX 1998-04-17

SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM

Applicant Med Institute, Inc.

K number K964001

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ITX 1998-04-09

LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60

Applicant Cosmaceutical Marketing, Inc.

K number K980091

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ITX 1998-03-18

ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER

Applicant Aloka Co., Ltd.

K number K974544

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ITX 1998-02-11

PHASED ARRAY TRANSDUCER - - PVF -375DT

Applicant Toshiba America Medical Systems, In.C

K number K972771

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ITX 1998-02-06

CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER

Applicant Clk Intl., Inc.

K number K974301

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ITX 1998-01-23

22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR

Applicant Cardiovascular Dynamics, Inc.

K number K973713

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ITX 1998-01-22

GENERAL PURPOSE ATL NEEDLE GUIDE KIT

Applicant Protek Medical Products, Inc.

K number K973958

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ITX 1998-01-12

SONOS 5500 IMAGING SYSTEM

Applicant Hewlett-Packard Co.

K number K971116

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ITX 1997-12-30

EVERYTIME TRANSFUCER COVER

Applicant Amedic AB

K number K955893

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ITX 1997-11-26

TRANSDUCER POSITIONER

Applicant Protek Medical Products, Inc.

K number K973622

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ITX 1997-11-05

L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM

Applicant Acuson Corp.

K number K973079

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ITX 1997-10-01

NEEDLE GUIDE/GRID

Applicant Protek Medical Products, Inc.

K number K973362

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ITX 1997-08-25

VIEWCATH 3-D CATHETER PULLBACK

Applicant Quinton, Inc.

K number K971397

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ITX 1997-08-15

DEVMED STEPPING AND STABILIZING SYSTEM

Applicant Devmed Corp.

K number K972152

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ITX 1997-07-30

INTRACAVITY NEEDLE GUIDE KIT

Applicant Arlanda Medicinska Instrument Co. AB

K number K955668

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ITX 1997-07-29

BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY

Applicant Barzell-Whitmore Maroon Bells, Inc.

K number K972672

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ITX 1997-07-24

HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM

Applicant Hewlett-Packard Co.

K number K972348

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ITX 1997-07-23

SLED, FINGER, HANDLE

Applicant Biosound Esaote, Inc.

K number K971942

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ITX 1997-07-10

TRANS VAGINAL NEEDLE GUIDE

Applicant Protek Medical Products, Inc.

K number K971722

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