FDA.reportPublic FDA data

James Clifford

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091567223009156722James Clifford1N2026-01-01800 MacArthur Blvd Mahwah NJ US 07430

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1937031561987362K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);DiagnosIYN2026-05-11
1937031586713285K260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)MHX2026-05-20
1937031090274816K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)BSZ2026-06-25
1937031202188887K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX2026-04-16
1937032012953005K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound SystemIYN2026-02-11
1937031818510059K252182SV70 Ventilator (SV70)MNT2026-04-06
1937031346608343K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound SystemIYN2025-11-07
1937031185206277K251820ViewMateTM Ultrasound SystemIYN2025-09-12
1937031051998070K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystemIYN2025-12-03
1937031699826019K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02)IYN2025-09-05
1937031812506504K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8)IYN2025-08-22
1937031929705408K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);IYN2025-05-16
1937031248811363K250024TE Air Diagnostic Ultrasound SystemIYN2025-05-30
1937031749048201K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); DiagnostIYN2025-05-19
1937031210198182K243767SV600, SV800 VentilatorCBK2025-08-28
1937031479877975K242728BeneVision Central Monitoring SystemMSX2025-07-31
1937031012676637K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound SystemIYN2024-11-08
1937031374848952K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemIYN2024-09-12
1937031600160214K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound SystemIYN2024-09-16
1937031545651374K240906TE Air Diagnostic Ultrasound SystemIYN2024-07-23
1937031960597073K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound SystemIYN2024-06-17
1937031232599565K240375V80 Anesthetic Vaporizer (V80)CAD2024-10-31
1937031774032624K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound SystemIYN2024-04-22
1937032047368973K231685TE Air Diagnostic Ultrasound SystemIYN2023-10-26
1937031244019039K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound SystemIYN2023-06-09
1937031909383755K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound SystemIYN2023-02-07
1937031446954314K222754ViewMate Multi Ultrasound SystemIYN2022-11-09
1937031259270929K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound SystemIYN2022-09-29
1937032043718839K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound SystemIYN2022-09-29
1937031503476650K221267VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs MonitorMWI2022-12-15
1937031268526229K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorMWI2022-12-02
1937031237159677K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound SystemIYN2022-03-25
1937031859545320K220107Mindray SV600 Ventilator, Mindray SV800 VentilatorCBK2023-06-16
1937031863106583K220051TE Air Diagnostic Ultrasound SystemIYN2022-03-04
1937031497357508K213799N Series Patient MonitorsMHX2022-07-12
1937031818644445K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemIYN2021-11-05
1937031044523092K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound SystemIYN2021-11-16
1937031304229916K211475Vital Signs MonitorsMWI2021-10-05
1937031472834614K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemIYN2021-07-01
1937032038232827K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound SystemIYN2021-06-10
1937031206630187K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound SystemIYN2021-06-10
1937031983599379K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemIYN2021-03-23
1937031375232757K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound SystemIYN2021-04-08
1937031114991249K202405BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1MHX2021-01-07
1937031881410812K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemIYN2020-11-09
1937031665026615K201957A8, A9 Anesthesia SystemBSZ2021-03-26
1937031703232891K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound SystemIYN2020-08-21
1937031931585585K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemIYN2020-05-28
1937031718573074K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/FibrousIYN2020-07-24
1937031873982951K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemIYN2020-04-08
1937031924571320K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemIYN2020-04-02
1937031809074725K200015ePM Series Patient monitorsMHX2020-06-08
1937031600580376K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound SystemIYN2020-04-09
1937031083614729K193391BeneVision Central Monitoring SystemMSX2020-05-21
1937031346981071K192972Patient MonitorMHX2020-05-07
1937031578498374K192410ZS3 and z.one pro Ultrasound SystemsIYN2019-12-19
1937031604478718K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound SystemIYN2019-12-13
1937031340664658K191769ePM Series Patient monitorsMHX2019-10-31
1937031194813864K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound SystemIYN2019-03-08
1937031789717880K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)MHX2019-07-10
1937031265143613K183660DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging SystemIYN2019-04-09
1937032021171959K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemIYN2019-04-04
1937031319712901K183238BeneVision Central Monitoring SystemMSX2019-03-13
1937031864094477K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorMWI2019-03-27
1937031874575842K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemIYN2019-01-10
1937031817126986K182603Z6 Diagnostic Ultrasound SystemIYN2018-11-14
1937031398481678K182075BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)MHX2018-12-10
1937031534411263K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemIYN2019-01-09
1937031989530612K180912TE7/TE5 Diagnostic Ultrasound SystemIYN2018-07-30
1937031513499363K180788Gas Module 3BZK2018-10-24
1937031772004620K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticIYN2018-01-08
1937031336491496K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemIYN2017-12-13
1937031311704371K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundIYN2017-10-25
1937031536398626K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)MHX2017-11-15
1937031865616245K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemIYN2017-09-21
1937031181666040K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemIYN2017-10-18
1937031249138353K171311A5 Anesthesia SystemBSZ2018-01-12
1937031894439252K171292A7 Anesthesia SystemBSZ2018-01-12
1937031226518104K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemIYN2017-09-12
1937031780323976K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound SystemIYN2017-07-10
1937031998020620K170876Passport Series Patient Monitors(Passport 12m, Passport 17m)MHX2017-08-23
1937031211063315K170712Accutorr 7/VS-900 Vital Signs MonitorMWI2017-08-02
1937031184485567K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemIYN2017-03-23
1937031734526822K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemIYN2017-04-20
1937031202075707K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemIYN2016-12-15
1937031578641833K162607BeneVision Central Monitoring SystemMSX2017-04-20
1937031619176645K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemIYN2016-09-06
1937031011421496K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemIYN2016-07-13
1937031542104099K160429BC-5390 Auto Hematology AnalyzerGKZ2016-09-01
1937031529815075K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry AnalyzerJGS2016-06-09
1937031469088567K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)MHX2016-03-03
1937031364602693K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)MHX2016-02-18
1937031673896375K152543M9/M9CV/M9T Diagnostic Ultrasound SystemIYN2015-10-29
1937031400211527K151954A7 Anesthesia SystemBSZ2015-10-27
1937031971538910K151175ZONARE ZS3 Diagnostic Ultrasound SystemIYN2015-05-15
1937031499374634K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemIYN2015-03-04
1937031892288415K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsIYN2015-04-10
1937031875890367K150167V60 Anesthetic VaporizerCAD2015-06-30
1937031729722000K150082Panorama Patient Monitoring NetworkMHX2015-09-02
1937031764451378K143348BC-3600 Auto Hematology AnalyzerGKZ2015-08-21
1937031985186196K140690BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZERCDQ2014-09-02
1937031425853006K140030DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEMIYN2014-02-19
1937031015669011K132779DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-11-19
1937031393712469K132038ACCUTORR 7 VITAL SIGNS MONITORMWI2014-05-02
1937031305569157K132037VITAL SIGNS MONITORMWI2014-05-16
1937031805789340K131690M7/M7T DIAGNOSTIC ULTRASOUND SYSTEMIYO2013-07-24
1937031645673114K130833DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMIYN2013-06-21
1937031672486507K130695Z5 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-06-19
1937031181311033K123211A5 ANESTHESIA DELIVERY SYSTEMBSZ2013-02-14
1937031563470718K122010Z6 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-07-20
1937031894689460K120699DC-T6 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-04-19
1937031864789516K113632DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMIYO2012-01-25
1937031910508119K112377BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZERCFR2012-03-23
1937031306894658K111435DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMIYO2011-07-08
1937031431841802K103583DC-7 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-12-27
1937031469509992K102991M5 DIAGNOSTIC ULTRASOUND SYSTEMIYO2010-10-22
1937031226077377K102865DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEMITX2010-11-03
1937031942000447K093394BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D CGKZ2010-04-08
1937031638970392K090912DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900ITX2009-04-15
1937031546227638K082887PM-1000F+PATIENT MONITORMWI2009-01-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN702026-05-11
MHX142026-05-20
MWI82022-12-15
BSZ62026-06-25
MSX42025-07-31
IYO42013-07-24
GKZ32016-09-01
CBK22025-08-28
CAD22024-10-31
CFR22012-03-23
ITX22010-11-03
MNT12026-04-06
BZK12018-10-24
JGS12016-06-09
CDQ12014-09-02