Panels › Cardiovascular › Product code DPW · Class 2
Flowmeter, Blood, Cardiovascular
Regulation 870.2100
3510(k)s in 12 months (138 all time)
1recalls in 12 months (35 all time)
31recalls that name a 510(k)
Top companies in DPW
| Company | 510(k)s | Recalls |
|---|---|---|
| Transonic Systems, Inc. | 5 | 10 |
| Koven Technology, Inc. | 7 | 1 |
| Baxter Healthcare Corp. | 0 | 7 |
| Vascular Technology Incorporated | 2 | 5 |
| Deltex Medical | 6 | 0 |
| Perimed AB | 6 | 0 |
| Koven and Assoc., Inc. | 5 | 0 |
| Parks Medical Electronics Inc | 0 | 5 |
| Cardio Metrics, Inc. | 4 | 0 |
| Flosonics Medical | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 8, 2002 | K013376 | QFLOW 500 PERFUSION MONITORING SYSTEM Hemedex Incorporated | DPW |
| Feb 13, 2002 | K013803 | FLOWGUARD DEVICE Biosonix , Ltd., IL | DPW |
| Feb 12, 2002 | K010452 | BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T Koven Technology, Inc. | DPW |
| Nov 6, 2001 | K011899 | PF 5050 PRESSURE UNIT, MODEL PF 5050 Perimed AB, SE | DPW |
| May 2, 2001 | K002186 | VASCULAR ASSIST Huntleigh Healthcare, Inc. | DPW |
| Nov 17, 2000 | K992529 | TISSUE SPECTROSCOPE Vital Medical , Ltd. | DPW |
| Aug 19, 1999 | K984338 | JOSTRA HL-20 TWIN PUMP Jostra Bentley | DPW |
| Aug 3, 1999 | K992388 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200 Rossmax International , Ltd., TW | DPW |
| Aug 3, 1999 | K992387 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100 Rossmax International , Ltd., TW | DPW |
| May 20, 1999 | K973078 | WRIST BLOOD PRESSURE METER MODEL SE-330 Sein Electronics Co., Ltd. | DPW |
| Nov 24, 1998 | K982986 | TUBING BLOOD FLOW METER MODEL NUMBER HD-800 Koven Technology, Inc. | DPW |
| Oct 14, 1998 | K973198 | VGF-7 VASCULAR GRAFT FLOWMETER Medicard , Ltd. | DPW |
| May 28, 1998 | K974285 | PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT Perimed, Inc. | DPW |
| Apr 30, 1998 | K970211 | MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR Micro Weiss Electronics | DPW |
| Apr 30, 1998 | K970139 | MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO Micro Weiss Electronics | DPW |
| Mar 13, 1998 | K972213 | MS-700 Alan S. Lee | DPW |
| Feb 24, 1998 | K972798 | DYNEMO 3000 Sometec, Inc. | DPW |
| Mar 29, 1996 | K954397 | BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY Koven Technology, Inc. | DPW |
| Nov 7, 1995 | K951369 | EDM Deltex Medical | DPW |
| Jun 29, 1995 | K951486 | MODEL PV2000 VASCULAR MICROLABORATORY Vasamedics, LLC | DPW |
| Dec 23, 1994 | K942613 | SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR Koven Technology, Inc. | DPW |
| Dec 7, 1993 | K932068 | PERITEMP PF 4005 HEATER Perimed, Inc. | DPW |
| Oct 12, 1993 | K921377 | P/METER Zertl Medical, Inc. | DPW |
| Sep 16, 1993 | K930227 | MS DISPOSABLE RIGID DOPPLER PROBE Meadox Medicals, Div. Boston Scientific Corp. | DPW |
| Aug 23, 1993 | K925524 | CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) Cardio Metrics, Inc. | DPW |
| May 18, 1993 | K922034 | LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER Titronics Medical Instruments, Inc. | DPW |
| Feb 3, 1993 | K922368 | PERIFLUX PF4001 LASER DOPPLER FLOWMETER Perimed, Inc. | DPW |
| Jan 29, 1993 | K922669 | MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW Koven and Assoc., Inc. | DPW |
| Jan 22, 1993 | K920333 | SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR Koven and Assoc., Inc. | DPW |
| Dec 10, 1992 | K915550 | MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR Koven and Assoc., Inc. | DPW |
| Jul 21, 1992 | K920844 | PIM 1.0 LASER DOPPLER PERFUSION IMAGER Lisca Development AB, SE | DPW |
| Jan 9, 1992 | K912562 | ABCOM 2000 Applied Biometrics, Inc. | DPW |
| Dec 12, 1991 | K912446 | MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 Vasamedics, LLC | DPW |
| Nov 19, 1991 | K913827 | MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG Hewlett-Packard Co. | DPW |
| Aug 13, 1991 | K911763 | LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) Vasamedics, LLC | DPW |
| Apr 29, 1991 | K910049 | INTERSPEC APOGEE, MODIFICATION Interspec, Inc. | DPW |
| Mar 29, 1991 | K905411 | FLOWIRE AND FLOMAP Cardio Metrics, Inc. | DPW |
| Feb 26, 1991 | K903026 | ES-1000SP II SMART DOP Koven and Assoc., Inc. | DPW |
| Feb 13, 1991 | K904317 | AVALON GENERAL PURPOSE SCANNER, PREVIEW GP Avalon Technology Corp. | DPW |
| Jan 28, 1991 | K904792 | DIAGNOSTIC ULTRASOUND VERSADOPP 1000 Diagnostic Ultrasound Corp. | DPW |
| Nov 7, 1990 | K903625 | DOPPLER NEEDLE AND FLOW MONITOR Peripheral Systems Group | DPW |
| Nov 5, 1990 | K901015 | WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC Wright Medical Corp. | DPW |
| Oct 9, 1990 | K903633 | ADVANCE LASER FLOWMETER, ALF 21 Transonic Systems, Inc. | DPW |
| Aug 10, 1990 | K901335 | ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER Ge Medical Systems Information Technologies | DPW |
| Aug 8, 1990 | K902088 | MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND Hewlett-Packard Co. | DPW |
| Jul 16, 1990 | K901733 | MODIFIED FLOCATH PULMONARY ARTERY CATHETER Cardio Metrics, Inc. | DPW |
| Feb 16, 1990 | K896613 | FLAT VASCULAR PROBE Imex Medical Systems, Inc. | DPW |
| Feb 13, 1990 | K896515 | LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2 Tsi, Inc. | DPW |
| Jan 19, 1990 | K894631 | NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW. Nihon Kohden America, Inc. | DPW |
| Jul 28, 1989 | K892707 | DVM-4200 BLOOD FLOWMETER Koven and Assoc., Inc. | DPW |
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