FDA.reportPublic FDA data

Marco Mu

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30038077573003807757Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30044968293004496829Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30047533883004753388Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30048591533004859153Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30050239973005023997Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30053272913005327291Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30061477053006147705Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30066333723006633372Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30066399443006639944Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30070310163007031016Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30075357343007535734Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30076494243007649424Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30076990813007699081Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30077034363007703436Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30083813003008381300Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30083884373008388437Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30084570783008457078Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30090771313009077131Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30094064333009406433Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30097977583009797758Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30103346503010334650Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30112195723011219572Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30115870773011587077Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30124659173012465917Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226
30130067753013006775Marco Mu1N2026-01-012219 Rimlang Drive, Suite 301 Bellingham WA US 98226

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
227081591298693K983067FINE-JECTFMI1998-10-30
1041101796720985K951041BLOOD PRESSURE CUFF 3DXQ1995-10-31
1041101924524458K951040BLOOD PRESSURE CUFF 2DXQ1995-10-31
245271729655068K950780AMSINO CERVICAL SCRAPERHHT1995-07-25
1900281671011198K940720BUSSE ISOLATION AND PROCEDURAL MASKSFXX1994-11-02
227081693928778K821537HENKE DISPOSABLE SYRINGEFMF1982-05-28
640081827836805K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6IYN2026-05-22
1025361024040870K250425Ultraviolet Phototherapy DeviceFTC2025-04-07
640081882883800K233697SonoMax Series Digital Color Doppler Ultrasound SystemIYN2024-08-09
227082041485237K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic NeedlesFMI2024-02-01
1041101693397114K231478Digital Blood Pressure Monitor (Model: YB-800)DXN2023-12-15
1041101154878391K230889Digital ThermometerFLL2024-04-03
1041101294023787K230859Aneroid SphygmomanometerDXQ2023-06-28
640082070837280K223570SonoAir Series Digital Color Doppler Ultrasound SystemIYN2023-03-31
1811471003201504K221598Wearable breast pumpHGX2022-12-09
227081797177558K221045Insulin Syringes without needleFMF2022-11-03
1900281872363136K214087Medical Face MaskFXX2022-03-08
227081646056010K213811Sterile Hypodermic Syringes for Single UseFMF2022-05-12
227081845999130K212514Safety Pen Needle for Single Use, Insulin Pen NeedlesFMI2022-04-29
1887161288766615K212364BLT Dental Implant SystemDZE2022-08-10
1737451375955852K210618Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump SeriesOCX2021-10-20
1900281075855267K210433Surgical Face Mask (Ear loops and Tie-on)FXX2021-06-07
1811471509813735K202802TT Electric Breast Pump, TT Double Electric Breast PumpHGX2021-08-26
640081240335004K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemIYN2021-02-25
640081640249365K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemIYN2021-02-25
640081070975246K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemIYN2021-02-26
640081502508245K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemIYN2021-02-26
640081576000778K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound SystemIYN2021-03-02
1041101635751059K201843Infrared ear and forehead thermometer, model YI-100FLL2020-10-23
640081841166830K200780XBit Series Digital Color Doppler Ultrasound SystemIYN2020-08-05
1887161448083100K192274BV Dental Implant SystemDZE2020-06-18
1939381660867637K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single useFMF2019-09-12
1041101404154470K182652COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10FLL2018-11-20
227081430400938K181447Safety insulin needle for single useFMI2019-03-12
1041101435072971K180984Maxcon Sharps ContainerMMK2019-01-03
640081533461108K180974CBit Series Digital Color Doppler Ultrasound SystemIYN2018-08-17
227081017005190K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single UseMEG2018-08-09
1041101018194192K180207Non-contact Infrared ThermometerFLL2018-11-28
1025361132161805K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsDQA2018-06-08
1737451566413370K172151Hysteroscopy SystemHGH2018-04-09
1290651416241623K171517Digital ElectrocardiographDPS2018-01-11
640081522389007K170870Site~Rite Halcyon Diagnostic Ultrasound SystemIYN2017-07-06
842581964152437K170861PremierNKB2017-08-04
1025361650859283K170536ECG Disposable Lead WireDSA2017-04-24
640081287511630K170374SonoBook Series Diagnostic Ultrasound SystemIYN2017-06-06
227081863928593K163578EasyTouch Safety Pen NeedleFMI2018-08-03
245271628664477K162590Bashan TDP Heat LampILY2017-02-14
227081593471630K162180Disposable Insulin SyringeFMF2016-12-29
640081189078222K162172EBit Series Diagnostic Ultrasound SystemIYN2016-09-14
1041101065013260K160999Infra-red forehead thermometerFLL2016-08-01
842581142600655K160320PremierMNI2016-04-01
1290651410017779K160092Digital ElectrocardiographDPS2016-02-12
640081959514922K153085Q Series Diagnostic Ultrasound SystemIYN2015-12-21
1175351183495599K152618PANTHER Cutter StaplerGDW2015-11-12
1290651693857265K152384Digital ElectrocardiographDPS2015-12-18
1811471623542459K151284Electric Double Breast PumpsHGX2015-12-21
640081450067338K150861QBit Series Diagnostic Ultrasound SystemIYN2015-07-28
1887161473778811K150388Dental Implant SystemDZE2015-11-12
1175351241487053K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsGDW2015-06-11
1811471420341559K142479MEGNA BREAST PUMPSHGX2015-02-24
1813261452202367K142206Dental UnitEIA2015-03-13
1817761364377544K141973DIODE LASER HAIR REMOVAL SYSTEMGEX2014-10-06
1290651068007251K141946DIGITAL ELECTROCARDIOGRAPHDPS2015-02-13
640081454596923K140364CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBEIYN2014-06-02
1795771064988627K140202TRAUSIM DENTAL IMPLANT SYSTEMDZE2014-12-12
842581896630862K133053MILESTONE SPINAL SYSTEMMAX2014-07-15
640081710079502K131305CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBEIYN2013-08-01
875731152281971K130410DENTAL UNIT WITH CHAIREIA2013-07-26
842581307228726K130340LOCKING BONE PLATES AND SCREWSHRS2013-04-05
842581618392753K123578ANTERIOR CERVICAL PLATE SYSTEMKWQ2013-02-01
1288771598765149K123483DIODE LASERGEX2013-04-21
842581047501969K122994INTRAMEDULLARY NAIL SYSTEMMNH2013-04-12
227081592508967K122787COMFORT EZFMF2012-12-06
640081188941286K121867SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMSIYN2012-08-02
227081785637204K121632COMFORT EZFMI2012-08-10
842581294421388K121312INTRAMEDULLARY NAIL SYSTEMHSB2012-10-24
640082066312460K120801CHISON DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-06-14
640081027168667K113359CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBEIYN2012-02-03
1288771696525964K113018APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORMGEX2012-12-14
640081929885527K112539CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBEIYO2012-01-30
1939381812440455K112057KDL SYRINGES AND NEEDLEFMF2011-12-14
245271668197562K111559SURGICAL MASKSFXX2011-09-16
1288771328551411K110434TRIXEL CO2 LASERGEX2011-04-19
1164241856845353K103587DISPOSABLE BLLOD COLLECTION NEEDLEFMI2011-04-06
1175351746123434K103470PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAPGDW2011-01-11
1025361191678000K102825BLOOD PRESSURE CUFFDXQ2011-03-02
1041101751319803K102718DIGITAL THERMOMETER; DIGITAL THERMOMETERFLL2010-12-13
1034261678933031K101000WELLMIEN SURGICAL MASKFXX2010-08-09
1290652050441908K100626DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200KNG2010-05-21
875731145023417K093971DENTAL HANDPIECEEFB2010-04-22
999841575622419K092970GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3HMHX2010-02-02
640081990843227K091877CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINALITX2009-09-02
1041101118616569K090014CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPEDXQ2009-04-09
1041101619206968K083043KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201DXN2008-10-27
1025361515124322K082846APK SPO2 PULSE OXIMETER SENSORDQA2009-04-03
999842004594525K082789G1B PULSE OXIMETERDQA2009-01-07
1041101457383219K082042GONGDONG DISPOSABLE SHARP CONTAINERMMK2008-09-03
875732071270156K080438DENTAL UNIT WITH CHAIREIA2008-04-04
640081511509340K072210CHISON, MODEL 8300IYO2007-08-24
260051120771627K071081CONTACT LENS CASELRX2007-05-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN202026-05-22
FLL122024-04-03
DXQ82023-06-28
FMI72024-02-01
FMF72022-11-03
HGX62022-12-09
FXX62022-03-08
DZE42022-08-10
MMK42019-01-03
DPS42018-01-11
GEX42014-10-06
DXN32023-12-15
DQA32018-06-08
GDW32015-11-12
EIA32015-03-13
IYO32012-01-30
NKB22017-08-04
ILY22017-02-14
MNI22016-04-01
MAX22014-07-15
HRS22013-04-05
KWQ22013-02-01
HSB22012-10-24
HHT21995-07-25
FTC12025-04-07
OCX12021-10-20
MEG12018-08-09
HGH12018-04-09
DSA12017-04-24
MNH12013-04-12
KNG12010-05-21
EFB12010-04-22
MHX12010-02-02
ITX12009-09-02
LRX12007-05-01
DRX12004-09-15