FDA.reportPublic FDA data

MINDRAY DS USA, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22218192221819MINDRAY DS USA, Inc.1Y2026-01-01800 MACARTHUR BLVD. Mahwah NJ US 07430

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
886661031048666K971923DRAGER-VAPOR 2000CAD1997-09-16
886661386859146K955925CBC-CAL PLUS HEMATOLOGY CALIBRATORKRX1996-02-29
886661231019015K843962CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLEJPK1984-11-01
886661478288446K250024TE Air Diagnostic Ultrasound SystemIYN2025-05-30
886661858272627K243767SV600, SV800 VentilatorCBK2025-08-28
886662011811716K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemIYN2024-09-12
886661294567601K241201TEX20/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
886661029506503K240684Resona 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
886661909399190K240115Resona 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
886661860397110K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound SystemIYN2023-06-09
886662002789477K222928Resona 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
886661137892183K222754ViewMate Multi Ultrasound SystemIYN2022-11-09
886661303358467K221496Consona 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
886661719262204K221300Consona 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
886661886718166K220058BeneVision Central Monitoring SystemMSX2022-06-01
886661673711858K213799N Series Patient MonitorsMHX2022-07-12
886661424707013K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemIYN2021-07-01
886661560798704K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemIYN2021-03-23
886661978439176K201693DC-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
886661044230447K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemIYN2020-05-28
886661604128357K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/FibrousIYN2020-07-24
886661751591928K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemIYN2020-04-08
886661381344591K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemIYN2020-04-02
886661763037789K200015ePM Series Patient monitorsMHX2020-06-08
886661658678375K192410ZS3 and z.one pro Ultrasound SystemsIYN2019-12-19
886661331756397K192152DC-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
886661817898037K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)MHX2019-07-10
886661752242813K183660DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging SystemIYN2019-04-09
886662029480667K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemIYN2019-04-04
886661529473393K183238BeneVision Central Monitoring SystemMSX2019-03-13
886661121424282K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorMWI2019-03-27
886661153199096K182603Z6 Diagnostic Ultrasound SystemIYN2018-11-14
886661791590759K182075BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)MHX2018-12-10
886661172459069K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemIYN2019-01-09
886661191521424K180912TE7/TE5 Diagnostic Ultrasound SystemIYN2018-07-30
886661141607067K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundIYN2017-10-25
886661832811552K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemIYN2017-09-21
886661591144412K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemIYN2017-10-18
886661680971653K171311A5 Anesthesia SystemBSZ2018-01-12
886661260527778K171292A7 Anesthesia SystemBSZ2018-01-12
886661791536475K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemIYN2017-09-12
886661730933409K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound SystemIYN2017-07-10
886661819446550K170712Accutorr 7/VS-900 Vital Signs MonitorMWI2017-08-02
886661462209005K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemIYN2017-03-23
886662055741456K160606BC-5D Hematology ControlJPK2016-09-01
886661916303381K160429BC-5390 Auto Hematology AnalyzerGKZ2016-09-01
886661620298629K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry AnalyzerJGS2016-06-09
886661392728200K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)MHX2016-03-03
886661793659560K151175ZONARE ZS3 Diagnostic Ultrasound SystemIYN2015-05-15
886661236610306K150167V60 Anesthetic VaporizerCAD2015-06-30
886661538888229K143348BC-3600 Auto Hematology AnalyzerGKZ2015-08-21
886661688115404K140690BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZERCDQ2014-09-02
886661151591121K140030DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEMIYN2014-02-19
886661475565146K132779DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-11-19
886661524247231K132037VITAL SIGNS MONITORMWI2014-05-16
886661535065564K130695Z5 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-06-19
886661495543834K123211A5 ANESTHESIA DELIVERY SYSTEMBSZ2013-02-14
886661818938052K120699DC-T6 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-04-19
886661903040446K113632DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMIYO2012-01-25
886661923336804K112377BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZERCFR2012-03-23
886661078615097K111435DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMIYO2011-07-08
886661812958108K103583DC-7 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-12-27
886661721792324K102991M5 DIAGNOSTIC ULTRASOUND SYSTEMIYO2010-10-22
886662007216652K102865DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEMITX2010-11-03
886661886516468K093394BC-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
886661346722894K090912DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900ITX2009-04-15
886661981727514K072018BS-200 CHEMISTRY ANALYZER, MODE BS-200CFR2008-02-01
886661428060841K042276D-VAPORCAD2004-09-23
886661035377969
886661073850143
886661191538493
886661258468558
886661274424194
886661283365548
886661283659786
886661379523723
886661434936203
886661440827396
886661458622638
886661519112647
886661643016484
886661660739183
886661685357848
886661753777426
886661829552928
886661893982009
886662001006543

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN372025-05-30
MHX52022-07-12
MWI32019-03-27
BSZ32018-01-12
GKZ32016-09-01
CAD32015-06-30
IYO32012-01-25
MSX22022-06-01
JPK22016-09-01
CFR22012-03-23
ITX22010-11-03
CBK12025-08-28
JGS12016-06-09
CDQ12014-09-02
KRX11996-02-29

PMN#