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412 FDA 510(k) clearances · Product code

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RecordFirmDate
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO (K071287)Shimadzu Medical Systems2008-01-09
ACUSON S2000 ULTRASOUND SYSTEM (K072786)Siemens Medical Solutions USA, Inc.2007-11-13
MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 (K072918)Toshibamedical Systems Corporation2007-10-29
APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM (K072826)Toshiba America Medical Systems, In.C2007-10-24
BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B (K070195)Broadsound Corporation2007-10-15
SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM (K072541)Senorx, Inc.2007-09-25
DC-6 DIAGNOSTIC ULTRASOUND SYSTEM (K072164)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2007-09-05
ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM (K072285)Aloka Co., Ltd.2007-08-30
ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM (K072266)Siemens Medical Solutions USA, Inc.2007-08-29
A-VIEW BASIC AND PLUS (K070515)Cordatec N.V.2007-07-30
MYLAB40 (K070903)Esaote Europe B.V.2007-07-02
GYNESONICS EC6 TRANSDUCER (K061153)Gynesonics, Inc.2006-10-27
SONOMARK (K061560)Medical Products Manufacturing, Inc.2006-08-18
SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 (K060947)Boston Scientific Corp2006-04-19
MODEL EC9-4 TRANSDUCER (K060879)Siemens Medical Solutions USA, Inc.2006-04-19
AIM ACCURACY IN MARKING SYSTEM (K053463)Georgene Austria2006-03-07
SITE-RITE 5 ULTRASOUND SYSTEM (K052517)C.R. Bard, Inc.2005-09-29
V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER (K052021)Siemens Medical Solutions USA, Inc.2005-08-17
FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT (K050320)Ascendia Medtech AB2005-08-15
SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM (K050724)C.R. Bard, Inc.2005-04-18
SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) (K043425)Sheathing Technologies, Inc.2005-02-28
TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES (K043278)Teratech Corp.2004-12-13
IOP8 INTRA OPERATIVE PROBE (K032315)Huntleigh Healthcare, Inc.2004-11-18
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 (K041818)Boston Scientific Corp2004-11-10
SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT (K042445)Bard Access Systems, Inc.2004-10-19
MHLX7EC TRANSDUCER (K040213)Microhelix, Inc.2004-09-22
TARGETSCAN BIOPSY KIT (K041638)Envisioneering, LLC2004-09-02
TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM (K041637)Envisioneering, LLC2004-09-01
EG-3830UT (K041397)Pentax Precision Instrument Corp.2004-06-09
EG-3630UR (K041395)Pentax Precision Instrument Corp.2004-06-09
FG-36UX FIBER ULTRASOUND GASTROSCOPE (K041396)Pentax Precision Instrument Corp.2004-06-09
TERATECH MODEL 10V5 SMART PROBE (K040840)Teratech Corp.2004-04-14
LATEX ULTRASONIC PROBE COVER (K022156)Pleasure Latex Products Sdn. Bhd.2003-09-11
CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 (K031920)Trans Vascular Incorporated2003-07-23
AMERITEK SURE-POINT TRACKER SYSTEM (K030518)Amertek Medical, Inc.2003-05-20
TRANSVAGINAL DOPPLER PROBE (K031358)Vascular Control Systems, Inc.2003-05-09
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY (K030064)Sonosite,Inc.2003-01-22
ATLANTIS PV IMAGING CATHETER, MODEL 36456 (K022860)Boston Scientific, Target2002-11-21
TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 (K023024)Vascular Control Systems, Inc.2002-09-26
COOK-SWARTZ DOPPLER FLOW PROBE (K022649)Cook Vascular, Inc.2002-09-06
CROSSPOINT TRANSACCESS CATHETER (K013363)Trans Vascular Incorporated2002-04-02
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER (K013723)Hitachi Medical Corp.2002-02-06
TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS (K014182)Tetrad Corp.2002-01-03
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER (K013721)CIVCO Medical Instruments Co., Inc.2001-12-28
SHAPEABLE DOPPLER FLOW PROBE (K002958)Cook Vascular, Inc.2001-12-18
TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS (K013849)Tetrad Corp.2001-12-03
SCANTAC MEMBRANE OR SCANTAC STRIP (K013170)Sonotech, Inc.2001-11-13
ULTRASOUND TRANSDUCER COVER (K011265)Advance Medical Designs, Inc.2001-10-30
WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL (K012522)National Therapy Products, Inc.2001-10-18
AMERITEK BRACHYTHERAPY TEMPLATE (K011581)Amertek Medical, Inc.2001-07-17
THIN FILM DRESSING FOR ULTRASOUND EXAM (K011284)Martin E. Wendelken2001-06-20
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM (K011314)Aloka Co., Ltd.2001-05-15
TETRAD TC-C3-ACP (K002193)Tetrad Corp.2001-05-04
TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE (K010883)Teratech Corp.2001-04-06
AT3C70 TRANSDUCER (K002856)Sonora Medical Systems2001-04-02
ALOKA UST-5280-5 (K002784)Aloka Co., Ltd.2000-09-20
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT (K994103)Olympus America, Inc.2000-09-05
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE (K994106)Olympus America, Inc.2000-06-02
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE (K994069)Olympus America, Inc.2000-06-02
OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT (K001203)The Olympus Optical Co.2000-05-26
BALLOON FOR ULTRASONIC ENDOSCOPES (K992178)N.M. Beale Co., Inc.2000-05-12
GE LOGIQ 700 (K001016)GE Medical Systems2000-04-24
HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4) (K994373)Atl Ultrasound, Inc.2000-03-24
MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 (K992305)Medi-Stim A/S1999-09-08
IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER (K982208)Jomed Imaging , Ltd.1999-08-27
GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF (K992152)CIVCO Medical Instruments Co., Inc.1999-08-17
THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER (K984639)Medison America, Inc.1999-07-12
VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7 (K992155)Medison America, Inc.1999-07-08
VIVOSONIC (K984562)Sonotech, Inc.1999-06-08
GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, (K991236)CIVCO Medical Instruments Co., Inc.1999-06-02
SCANFLEX SOLID COUPLANT MEMBRANE (K983691)Sonotech, Inc.1999-05-05
SHEATHES (NON-LATEX), STERILE (K990175)Sheathing Technologies, Inc.1999-04-21
HYBRISONIC SHEATH (K983985)Sonotech, Inc.1999-02-25
LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM (K990400)Hewlett-Packard Co.1999-02-24
BLADDERMANAGER PCI 5000 MODEL 1002 (K982568)Diagnostic Ultrasound Corp.1999-01-25
VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) (K982329)Endosonics Corp.1999-01-14
OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE (K982323)Olympus America, Inc.1998-12-11
OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) (K982610)Olympus Optical, Co.1998-11-16
OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE (K982733)The Olympus Optical Co.1998-10-28
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE (K982725)Olympus America, Inc.1998-10-23
ULTRA-COVER PU-TRANSDUCER COVER (K981069)International Medical Products B.V.1998-09-23
ULTRA IMAGE AND ULTRA SCAN (K981028)Sonotech, Inc.1998-08-21
EUP-OL334 LAPARASCOPICPROBE (K981434)Hitachi Medical Corp. of America1998-07-27
SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM (K964001)Med Institute, Inc.1998-04-17
LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60 (K980091)Cosmaceutical Marketing, Inc.1998-04-09
ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER (K974544)Aloka Co., Ltd.1998-03-18
PHASED ARRAY TRANSDUCER - - PVF -375DT (K972771)Toshiba America Medical Systems, In.C1998-02-11
CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER (K974301)Clk Intl., Inc.1998-02-06
22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR (K973713)Cardiovascular Dynamics, Inc.1998-01-23
GENERAL PURPOSE ATL NEEDLE GUIDE KIT (K973958)Protek Medical Products, Inc.1998-01-22
SONOS 5500 IMAGING SYSTEM (K971116)Hewlett-Packard Co.1998-01-12
EVERYTIME TRANSFUCER COVER (K955893)Amedic AB1997-12-30
TRANSDUCER POSITIONER (K973622)Protek Medical Products, Inc.1997-11-26
L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM (K973079)Acuson Corp.1997-11-05
NEEDLE GUIDE/GRID (K973362)Protek Medical Products, Inc.1997-10-01
VIEWCATH 3-D CATHETER PULLBACK (K971397)Quinton, Inc.1997-08-25
DEVMED STEPPING AND STABILIZING SYSTEM (K972152)Devmed Corp.1997-08-15
INTRACAVITY NEEDLE GUIDE KIT (K955668)Arlanda Medicinska Instrument Co. AB1997-07-30
BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY (K972672)Barzell-Whitmore Maroon Bells, Inc.1997-07-29
HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM (K972348)Hewlett-Packard Co.1997-07-24
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