Monitor, Ultrasonic, Nonfetal
Regulation 892.1540
0510(k)s in 12 months (38 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in JAF
| Company | 510(k)s | Recalls |
|---|---|---|
| Natus Neurology Inc | 0 | 4 |
| Unetixs Vascular, Inc. | 0 | 4 |
| Imex Medical Systems, Inc. | 3 | 0 |
| Thd Spa | 3 | 0 |
| Biomedix, Inc. | 2 | 0 |
| Kt Medical, Inc. | 2 | 0 |
| L&M Ultrascope Life Monitoring Sys. | 2 | 0 |
| Medasonics, Inc. | 2 | 0 |
| Nicolet Biomedical | 2 | 0 |
| Philips Medical Systems, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 13, 2024 | K242487 | Laminar P1 (LDH-HW-001) Laminar Digital Health, Inc. | JAF |
| Feb 24, 2015 | K141657 | THD REVOLUTION Thd Spa, IT | JAF |
| May 12, 2011 | K110628 | SIMPLEABI Newman Medical | JAF |
| Dec 24, 2009 | K093393 | LIFEDOP MODEL 300ABI Summit Doppler Systems, Inc. | JAF |
| Jan 28, 2009 | K090009 | THD SLIDE ONE Thd Spa | JAF |
| Jul 30, 2008 | K081429 | THD SLIDE Thd Spa | JAF |
| Jun 20, 2007 | K070815 | THD G.F. S.R.L. | JAF |
| Dec 19, 2006 | K063600 | VISTA AVS Summit Doppler Systems, Inc. | JAF |
| Apr 10, 2006 | K060064 | STETHOFLUX Odvi, FR | JAF |
| Aug 29, 2005 | K052067 | DOPPLER GUIDED PROCTOSCOPE, MODEL 500H Multigon Industries, Inc. | JAF |
| Mar 9, 2001 | K010521 | NICOLET VERSALAB Nicolet Biomedical | JAF |
| Aug 7, 1998 | K982635 | CAREDOP II Nicolet Biomedical | JAF |
| Feb 5, 1998 | K973336 | IMEX STETHODOP Imex Medical Systems, Inc. | JAF |
| Dec 29, 1997 | K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) Biomedix, Inc. | JAF |
| Dec 23, 1997 | K973644 | FLOSTAT VASCULAR LAB Biomedix, Inc. | JAF |
| Apr 12, 1996 | K943338 | BIOSENSOR BIDOP VASCULAR TEST SYSTEM Biosensor Corp. | JAF |
| Nov 21, 1995 | K943200 | FLOSCOPE SUPER VASCULAR LAB Advance Medical Device, Inc. | JAF |
| May 12, 1995 | K944196 | IMWXDOP IR Imex Medical Systems, Inc. | JAF |
| Oct 21, 1994 | K935427 | R AND D BATTERIES R & D Batteries, Inc. | JAF |
| Aug 23, 1994 | K942441 | IMEXDOP CT+ Imex Medical Systems, Inc. | JAF |
| Jun 18, 1992 | K912925 | ULTRA PVD Advanced Medical Products, Inc. | JAF |
| Oct 15, 1991 | K912033 | ULTRASOUND STETHOSCOPE(R) INTRADOP(R) Medadonics, Inc. | JAF |
| Apr 29, 1991 | K904392 | MULTILAB 2000 Unetixs, Inc. | JAF |
| Aug 22, 1990 | K900882 | MULTI DOPPLEX, MD-1 Huntleigh Technology, Inc. | JAF |
| Sep 21, 1988 | K882018 | MEDACORD PVL, PERSONAL VASCULAR LABORATORY Medasonics, Inc. | JAF |
| Apr 23, 1986 | K854591 | SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ Philips Medical Systems, Inc. | JAF |
| Apr 23, 1986 | K854590 | HANDHELD DOPLER/PEN TRANSDUCER 3MHZ Philips Medical Systems, Inc. | JAF |
| Nov 26, 1985 | K851149 | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 Keymed, Inc., GB | JAF |
| Sep 19, 1985 | K852572 | 3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802 Siemens Medical Solutions USA, Inc. | JAF |
| Feb 25, 1985 | K844128 | EUB-40 Hitachi Medical Corp. of America | JAF |
| Feb 13, 1985 | K843933 | VINGMED DS100 DOPPLER FLOWMETER Vingmed, Inc. | JAF |
| Nov 29, 1984 | K842408 | IREX 730 MECHANICAL SECTOR SCANNER Irex Corp. | JAF |
| Sep 17, 1982 | K822602 | HEMACOUNT WRIGHT GIEMSA STAIN PACK Accra Laboratories, Inc. | JAF |
| Jul 8, 1980 | K800768 | VASCULAB BI-DIRECTIONAL DOPPLER, #D10 Medasonics, Inc. | JAF |
| Feb 11, 1980 | K800097 | MINIVASON 9 Kt Medical, Inc. | JAF |
| Feb 11, 1980 | K800096 | AMBIVASON DR-200 Kt Medical, Inc. | JAF |
| Mar 2, 1978 | K780201 | SPEAKER-AMPLIFIER & RECORDER INTERFACE L&M Ultrascope Life Monitoring Sys. | JAF |
| Mar 2, 1978 | K780200 | ULTRASCOPE L&M Ultrascope Life Monitoring Sys. | JAF |
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