ClearanceBrief
Panels › Radiology › Product code ITX · Class 2

Transducer, Ultrasonic, Diagnostic

Regulation 892.1570

6510(k)s in 12 months (415 all time)
13recalls in 12 months (147 all time)
118recalls that name a 510(k)
Get daily alerts for ITXSample briefCSV

Top companies in ITX

Company510(k)sRecalls
CIVCO Medical Instruments Co., Inc.1628
Philips Ultrasound, Inc.339
Exact Medical Manufacturing218
Biosound, Inc.130
Boston Scientific102
Siemens Medical Solutions USA, Inc.75
Acuson Corp.110
General Electric Co.110
Acuson Computed Sonography100
Toshiba America Medical Systems, In.C90
Decided510(k)Device and applicantCode
Oct 30, 2001K011265ULTRASOUND TRANSDUCER COVER
Advance Medical Designs, Inc.
ITX
Oct 18, 2001K012522WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL
National Therapy Products, Inc., CA
ITX
Jul 17, 2001K011581AMERITEK BRACHYTHERAPY TEMPLATE
Amertek Medical, Inc.
ITX
Jun 20, 2001K011284THIN FILM DRESSING FOR ULTRASOUND EXAM
Martin E. Wendelken
ITX
May 15, 2001K011314OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
Aloka Co., Ltd.
ITX
May 4, 2001K002193TETRAD TC-C3-ACP
Tetrad Corp.
ITX
Apr 6, 2001K010883TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
Teratech Corp.
ITX
Apr 2, 2001K002856AT3C70 TRANSDUCER
Sonora Medical Systems
ITX
Sep 20, 2000K002784ALOKA UST-5280-5
Aloka Co., Ltd.
ITX
Sep 5, 2000K994103OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT
Olympus America, Inc.
ITX
Jun 2, 2000K994106OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE
Olympus America, Inc.
ITX
Jun 2, 2000K994069OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE
Olympus America, Inc.
ITX
May 26, 2000K001203OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT
The Olympus Optical Co.
ITX
May 12, 2000K992178BALLOON FOR ULTRASONIC ENDOSCOPES
N.M. Beale Co., Inc.
ITX
Apr 24, 2000K001016GE LOGIQ 700
GE Medical Systems
ITX
Mar 24, 2000K994373HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4)
Atl Ultrasound, Inc.
ITX
Sep 8, 1999K992305MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
Medi-Stim A/S, NO
ITX
Aug 27, 1999K982208IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER
Jomed Imaging , Ltd., GB
ITX
Aug 17, 1999K992152GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF
CIVCO Medical Instruments Co., Inc.
ITX
Jul 12, 1999K984639THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER
Medison America, Inc.
ITX
Jul 8, 1999K992155VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7
Medison America, Inc.
ITX
Jun 8, 1999K984562VIVOSONIC
Sonotech, Inc.
ITX
Jun 2, 1999K991236GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER,
CIVCO Medical Instruments Co., Inc.
ITX
May 5, 1999K983691SCANFLEX SOLID COUPLANT MEMBRANE
Sonotech, Inc.
ITX
Apr 21, 1999K990175SHEATHES (NON-LATEX), STERILE
Sheathing Technologies, Inc.
ITX
Feb 25, 1999K983985HYBRISONIC SHEATH
Sonotech, Inc.
ITX
Feb 24, 1999K990400LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM
Hewlett-Packard Co.
ITX
Jan 25, 1999K982568BLADDERMANAGER PCI 5000 MODEL 1002
Diagnostic Ultrasound Corp.
ITX
Jan 14, 1999K982329VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
Endosonics Corp.
ITX
Dec 11, 1998K982323OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE
Olympus America, Inc.
ITX
Nov 16, 1998K982610OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)
Olympus Optical, Co.
ITX
Oct 28, 1998K982733OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE
The Olympus Optical Co.
ITX
Oct 23, 1998K982725OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
Olympus America, Inc.
ITX
Sep 23, 1998K981069ULTRA-COVER PU-TRANSDUCER COVER
International Medical Products B.V., NL
ITX
Aug 21, 1998K981028ULTRA IMAGE AND ULTRA SCAN
Sonotech, Inc.
ITX
Jul 27, 1998K981434EUP-OL334 LAPARASCOPICPROBE
Hitachi Medical Corp. of America
ITX
Apr 17, 1998K964001SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM
Med Institute, Inc.
ITX
Apr 9, 1998K980091LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60
Cosmaceutical Marketing, Inc.
ITX
Mar 18, 1998K974544ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER
Aloka Co., Ltd.
ITX
Feb 11, 1998K972771PHASED ARRAY TRANSDUCER - - PVF -375DT
Toshiba America Medical Systems, In.C
ITX
Feb 6, 1998K974301CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER
Clk Intl., Inc.
ITX
Jan 23, 1998K97371322 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR
Cardiovascular Dynamics, Inc.
ITX
Jan 22, 1998K973958GENERAL PURPOSE ATL NEEDLE GUIDE KIT
Protek Medical Products, Inc.
ITX
Jan 12, 1998K971116SONOS 5500 IMAGING SYSTEM
Hewlett-Packard Co.
ITX
Dec 30, 1997K955893EVERYTIME TRANSFUCER COVER
Amedic AB, SE
ITX
Nov 26, 1997K973622TRANSDUCER POSITIONER
Protek Medical Products, Inc.
ITX
Nov 5, 1997K973079L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM
Acuson Corp.
ITX
Oct 1, 1997K973362NEEDLE GUIDE/GRID
Protek Medical Products, Inc.
ITX
Aug 25, 1997K971397VIEWCATH 3-D CATHETER PULLBACK
Quinton, Inc.
ITX
Aug 15, 1997K972152DEVMED STEPPING AND STABILIZING SYSTEM
Devmed Corp.
ITX

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.