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)
Top companies in ITX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 1997 | K955668 | INTRACAVITY NEEDLE GUIDE KIT Arlanda Medicinska Instrument Co. AB, SE | ITX |
| Jul 29, 1997 | K972672 | BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY Barzell-Whitmore Maroon Bells, Inc. | ITX |
| Jul 24, 1997 | K972348 | HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM Hewlett-Packard Co. | ITX |
| Jul 23, 1997 | K971942 | SLED, FINGER, HANDLE Biosound Esaote, Inc. | ITX |
| Jul 10, 1997 | K971722 | TRANS VAGINAL NEEDLE GUIDE Protek Medical Products, Inc. | ITX |
| Jul 9, 1997 | K971700 | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER Biosound, Inc. | ITX |
| Jun 20, 1997 | K970515 | GENERAL PURPOSE LATEX TRANSDUCER COVERS CIVCO Medical Instruments Co., Inc. | ITX |
| Jun 20, 1997 | K970514 | DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE CIVCO Medical Instruments Co., Inc. | ITX |
| Jun 20, 1997 | K970513 | GENERAL PURPOSE TRANDUCER COVER CIVCO Medical Instruments Co., Inc. | ITX |
| Jun 20, 1997 | K970049 | BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ Cardiovascular Imaging Systems, Inc. | ITX |
| Jun 13, 1997 | K971115 | GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE Protek Medical Products, Inc. | ITX |
| Jun 3, 1997 | K964549 | ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER Aloka Co., Ltd. | ITX |
| Apr 24, 1997 | K963989 | P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE Cardiovascular Dynamics, Inc. | ITX |
| Mar 17, 1997 | K970034 | SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. | ITX |
| Mar 10, 1997 | K964865 | PVK-720ST ENDOCAVITARY TRANSDUCER Toshiba America Medical Systems, In.C | ITX |
| Mar 4, 1997 | K970047 | PHASED ARRAY TRANSDUCER - - PSK-20CT Toshiba America Medical Systems, In.C | ITX |
| Feb 14, 1997 | K964658 | OASIS Sonotech, Inc. | ITX |
| Feb 10, 1997 | K963831 | SHEATHES (NON-LATEX) Medical Resources | ITX |
| Feb 10, 1997 | K961974 | FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE Pentax Precision Instrument Corp. | ITX |
| Feb 6, 1997 | K963302 | TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM Tayman Medical, Inc. | ITX |
| Jan 22, 1997 | K961002 | DIASONICS ITNRAOPERATIVE PROBES Diasonics Ultrasound | ITX |
| Dec 23, 1996 | K962840 | ECOLOTION TRANSMISSION AND MASSAGE LOTION Eco-Med Pharmaceuticals, Inc., CA | ITX |
| Dec 23, 1996 | K962093 | ULTRAMIX Sonotech, Inc. | ITX |
| Nov 12, 1996 | K963169 | RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL Rapid-Aid Ltd./Ltee, CA | ITX |
| Oct 25, 1996 | K951567 | CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE Cardio Metrics, Inc. | ITX |
| Sep 16, 1996 | K962293 | ENDOSONICS AUTOMATIC PULL BACK DEVICE Endosonics Corp. | ITX |
| Aug 22, 1996 | K961692 | SONOSCAN Sonotech, Inc. | ITX |
| Jul 25, 1996 | K961757 | ECOGEL 100 ULTRASOUND GEL Eco-Med Pharmaceuticals, Inc., CA | ITX |
| Apr 17, 1996 | K953716 | INTRACAVITY TRANSDUCERS Biosound, Inc. | ITX |
| Mar 1, 1996 | K953819 | DIAGNOSTIC ULTRASOUND TRANDUCER Biosound, Inc. | ITX |
| Mar 1, 1996 | K953759 | DIAGNOSTIC ULTRASOUND TRANSDUCER Biosound, Inc. | ITX |
| Feb 21, 1996 | K955246 | ECOGEL 200 ULTRASOUND GEL Eco-Med Pharmaceuticals, Inc., CA | ITX |
| Feb 12, 1996 | K955458 | ULTRASOUND PROBE BIOPSY ACCESSORIES Biosound, Inc. | ITX |
| Feb 12, 1996 | K952892 | OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) Olympus America, Inc. | ITX |
| Feb 2, 1996 | K953579 | TEE PROBE Biosound, Inc. | ITX |
| Nov 14, 1995 | K951723 | GE B510 TRANSDUCER GE Medical Systems | ITX |
| Oct 24, 1995 | K953430 | ULTRASOUND PROBE BIOPSY ACCESSORIES Biosound, Inc. | ITX |
| Sep 18, 1995 | K941935 | LP-12 LAPAROSCOPIC PROBE Biosound, Inc. | ITX |
| Jul 26, 1995 | K946300 | DOPPLEX SURGICAL PROBES Hne Healthcare, Inc. | ITX |
| Jun 19, 1995 | K951145 | VMI 1000 SURGICAL PACEOMETER Vision Medical Instruments, Inc. | ITX |
| Jun 13, 1995 | K944017 | OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM Olympus America, Inc. | ITX |
| Jun 2, 1995 | K944287 | 7050 ULTRASOUND IMAGING SYSTEM Biosound, Inc. | ITX |
| May 24, 1995 | K945796 | SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM Sharplan Lasers, Inc. | ITX |
| May 11, 1995 | K945320 | TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL Tetra Corp. | ITX |
| May 11, 1995 | K935994 | PW DOPPLER VASCULAR PROBES Koven Technology, Inc. | ITX |
| May 5, 1995 | K945318 | TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA Tetra Corp. | ITX |
| May 4, 1995 | K945319 | TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT Tetra Corp. | ITX |
| Apr 10, 1995 | K944610 | OLYMPUS ULTRASONIC PROBES Olympus America, Inc. | ITX |
| Mar 2, 1995 | K942296 | V5M Acuson Corp. | ITX |
| Mar 2, 1995 | K935595 | ACUSON MODEL 3001 Acuson Corp. | ITX |
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