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 |
|---|---|---|---|
| Jun 20, 1989 | K890828 | PERIFLUX PF3 Perimed, Inc. | DPW |
| Nov 7, 1988 | K882138 | IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER Imex Medical Systems, Inc. | DPW |
| Sep 19, 1988 | K875179 | MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A Tsi, Inc. | DPW |
| Aug 29, 1988 | K882593 | MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM Cardio Metrics, Inc. | DPW |
| Jun 21, 1988 | K872048 | TRANSONIC FLOWMETER Transonic Systems, Inc. | DPW |
| Feb 5, 1988 | K874885 | LAWRENCE L3000 CARDIAC OUTPUT MONITOR Lawrence Medical Systems, Inc. | DPW |
| Dec 7, 1987 | K871490 | COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION Ge Medical Systems Information Technologies | DPW |
| Sep 30, 1987 | K872068 | HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD Advanced Technology Laboratories, Inc. | DPW |
| Feb 20, 1987 | K864259 | MODIFIED LASERFLO BLOOD PERFUSION MONITOR Tsi, Inc. | DPW |
| Jan 5, 1987 | K853952 | METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME Metriflow, Inc. | DPW |
| Nov 26, 1986 | K863210 | VELCOM-100 Waters Instruments, Inc. | DPW |
| Nov 17, 1986 | K862720 | VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES Sonicaid, Inc. | DPW |
| Nov 17, 1986 | K861023 | DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER Diagnostic Electronics Corp. | DPW |
| Nov 10, 1986 | K862841 | HIGH VELOCITY CW DOPPLER SYSTEM Biosound, Inc. | DPW |
| Jul 29, 1986 | K860766 | MILLAR PULSED DOPPLER VELOCIMETER Millar Instruments, Inc. | DPW |
| Jul 18, 1986 | K860651 | MICRON, MICROVASCULAR DOPPLER Diagnostic Electronics Corp. | DPW |
| Feb 26, 1986 | K854500 | HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER - Medpacific Corp. | DPW |
| Aug 14, 1985 | K850137 | TECA TC2-64 TRANSCRANIAL DOPPLER Teca, Inc. | DPW |
| Jun 24, 1985 | K851057 | LASERFLO BLOOD PERFUSION MONITOR 403 Tsi, Inc. | DPW |
| May 16, 1985 | K840522 | RECOMED BLOOD-FLOW METER H236-052-02 Litton Medical Electronics | DPW |
| Mar 1, 1985 | K840169 | PHONOANGIOGRAPHIC SPECTRAL ANALYZER Biotronics Instruments | DPW |
| Feb 20, 1985 | K844631 | PERIFLUX PF-2 Medex, Inc. | DPW |
| Jul 8, 1982 | K821373 | XOMED PATENCY MONITOR Xomed, Inc. | DPW |
| Apr 15, 1982 | K820742 | NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100 Nihon Kohden America, Inc. | DPW |
| Mar 12, 1982 | K820272 | CLINIFLOW II, #701, ELECTROMAGN. BLD. SY Carolina Medical Electronics | DPW |
| Feb 4, 1982 | K812005 | CAPILLARY PERFUSION MONITOR #LD5000 Nuclear Pacific, Inc. | DPW |
| Aug 13, 1981 | K811616 | BACH-SIMPSON MODEL TS266 Bach-Simpson , Ltd. | DPW |
| Aug 13, 1981 | K811615 | BACH-SIMPSON MODEL BVM30 Bach-Simpson , Ltd. | DPW |
| Aug 13, 1981 | K811376 | ULTRASONIC QFM SYSTEM 1000 Narco Bio-Systems | DPW |
| Aug 12, 1981 | K811246 | DOPPLER ULTRASOUND BLOOD FLOWMETER Irex Corp. | DPW |
| Apr 10, 1981 | K810561 | DOPSCAN MODEL 1050 Carolina Medical Electronics | DPW |
| Jan 2, 1981 | K801802 | ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE Medical Testing System, Inc. | DPW |
| Feb 5, 1980 | K800151 | EMIT TOBRAMYCIN CONTROL Syva Co. | DPW |
| Oct 4, 1979 | K791418 | VASCULIZER Diagnostics Intl. | DPW |
| Apr 21, 1978 | K780302 | BLOOD FLOWMETER SYSTEM Medtronic Vascular | DPW |
| Feb 1, 1977 | K770115 | ARTERIAL DIAGNOSTIC UNIT (ADU) Medical Electronic Devices, Inc. | DPW |
| Dec 28, 1976 | K761288 | P-1 ULTRASONIC ARTERIOGRAPH D. Eugene Hokanson | DPW |
| Oct 13, 1976 | K760751 | CONTINUOUS WAVE DOPPLER Medsonics | DPW |
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