Atlas FDA

JAF

38 FDA 510(k) clearances · Product code

93 daysmedian time to decision
345 days90th percentile
38clearances measured

FDA profile

Official device name
Monitor, Ultrasonic, Nonfetal
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1540
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2014: 8 · 2017: 44
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Laminar P1 (LDH-HW-001) (K242487)Laminar Digital Health, Inc.2024-12-13
THD REVOLUTION (K141657)Thd Spa2015-02-24
SIMPLEABI (K110628)Newman Medical2011-05-12
LIFEDOP MODEL 300ABI (K093393)Summit Doppler Systems, Inc.2009-12-24
THD SLIDE ONE (K090009)Thd Spa2009-01-28
THD SLIDE (K081429)Thd Spa2008-07-30
THD (K070815)G.F. S.R.L.2007-06-20
VISTA AVS (K063600)Summit Doppler Systems, Inc.2006-12-19
STETHOFLUX (K060064)Odvi2006-04-10
DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (K052067)Multigon Industries, Inc.2005-08-29
NICOLET VERSALAB (K010521)Nicolet Biomedical2001-03-09
CAREDOP II (K982635)Nicolet Biomedical1998-08-07
IMEX STETHODOP (K973336)Imex Medical Systems, Inc.1998-02-05
FLOSTAT VASCULAR REPORT GENERATOR (VRG) (K973857)Biomedix, Inc.1997-12-29
FLOSTAT VASCULAR LAB (K973644)Biomedix, Inc.1997-12-23
BIOSENSOR BIDOP VASCULAR TEST SYSTEM (K943338)Biosensor Corp.1996-04-12
FLOSCOPE SUPER VASCULAR LAB (K943200)Advance Medical Device, Inc.1995-11-21
IMWXDOP IR (K944196)Imex Medical Systems, Inc.1995-05-12
R AND D BATTERIES (K935427)R & D Batteries, Inc.1994-10-21
IMEXDOP CT+ (K942441)Imex Medical Systems, Inc.1994-08-23
ULTRA PVD (K912925)Advanced Medical Products, Inc.1992-06-18
ULTRASOUND STETHOSCOPE(R) INTRADOP(R) (K912033)Medadonics, Inc.1991-10-15
MULTILAB 2000 (K904392)Unetixs, Inc.1991-04-29
MULTI DOPPLEX, MD-1 (K900882)Huntleigh Technology, Inc.1990-08-22
MEDACORD PVL, PERSONAL VASCULAR LABORATORY (K882018)Medasonics, Inc.1988-09-21
SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ (K854591)Philips Medical Systems, Inc.1986-04-23
HANDHELD DOPLER/PEN TRANSDUCER 3MHZ (K854590)Philips Medical Systems, Inc.1986-04-23
KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 (K851149)Keymed, Inc.1985-11-26
3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802 (K852572)Siemens Medical Solutions USA, Inc.1985-09-19
EUB-40 (K844128)Hitachi Medical Corp. of America1985-02-25
VINGMED DS100 DOPPLER FLOWMETER (K843933)Vingmed, Inc.1985-02-13
IREX 730 MECHANICAL SECTOR SCANNER (K842408)Irex Corp.1984-11-29
HEMACOUNT WRIGHT GIEMSA STAIN PACK (K822602)Accra Laboratories, Inc.1982-09-17
VASCULAB BI-DIRECTIONAL DOPPLER, #D10 (K800768)Medasonics, Inc.1980-07-08
AMBIVASON DR-200 (K800096)Kt Medical, Inc.1980-02-11
MINIVASON 9 (K800097)Kt Medical, Inc.1980-02-11
ULTRASCOPE (K780200)L&M Ultrascope Life Monitoring Sys.1978-03-02
SPEAKER-AMPLIFIER & RECORDER INTERFACE (K780201)L&M Ultrascope Life Monitoring Sys.1978-03-02

Track JAF automatically

Every clearance here is in the API, with alerts when new ones post.