FDA.reportPublic FDA data

PLATINUM FOCUS GROUP LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30304468443030446844PLATINUM FOCUS GROUP LTD.1N2026-01-01Unit 5, 1000 North Circular Road London London, City of GB NW2 7JP

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3251851774667100P160022X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™MKJ2017-12-27
3251851528992639K992257NEW MULTIPLES REAGENT STRIPSJIR1999-11-24
3251851776120183K991729FERRIS POLYOSTOMY STERILE WOUND DRESSINGKMF1999-08-27
3251851860381278K984577DRAGER OXYLOG 2000CBK1999-01-22
3251851655780343K983610CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18CAH1999-04-30
3251852068290116K982541VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608FMI1998-10-28
3251851947165067K980005MANAN D BAGEXF1998-01-30
3251851515998746K9551033M NO STING BARRIER FILMKMF1996-02-05
3251851852190710K953522USCI IDEAL PTCA KITMAV1996-04-17
3251851360918997K945660AUTOJECT 2KZH1995-08-11
3251851101540666K944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESJOH1994-10-27
3251851855081285K932913FERRIS POLYMEM HYDROPHILIC WOUND DRESSINGKMF1994-06-07
3251851178977088K914419AMNIOTEST(TM)HIO1993-09-01
3251851667045401K914088BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBEJOH1991-10-23
3251852028027582K911740SALTER LABS NEONATAL NASAL OXYGEN CANNULACAT1991-07-24
3251851736191008K911427BREATHING FILTERSCAH1991-08-26
3251851478795842K904185SENSATRACEDRX1990-10-31
3251851433820950K871412CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRODRX1987-05-12
3251851284002129K863280DERMAMARKERFZZ1986-09-09
3251851948264409K842115SPUNGARD & SURG. DRAPES-GOWNS & PACKSKKX1984-06-11
3251851097254297K831931ATRIUM THORACIC CATHETERGBZ1983-10-04
3251851642036441K823882M-BRACEIPY1983-01-17
3251851223220645K823707HOSPAL BLOOD LINESKOC1983-01-05
3251851191116383K813140VYGON EXTENSION TUBES & CONNECTORSDQO1981-11-27
3251851808354845K792218MISTY BEBULIZERCAF1979-11-27
3251851284615757K791495LUKENS BONE WAX (GAMMA RADIATION)MTJ1979-09-24
3251851255541013K781922PULMONARY MONITORBZH1979-02-13
3251851972830925K781548UMBILICAL CORD CLAMPHFW1978-10-17
3251851875469723K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetPTI2024-11-27
3251851824951544K240589Micropuncture Introducer Sets; Micropuncture Pedal Access SetsDYB2024-03-25
3251851099499669K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ LancetsFMK2022-12-16
3251851472533923K222744Sol-M Luer Lock SyringeFMF2022-10-11
3251851235734510K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceJKA2023-03-10
3251851216850157K220137Lunderquist Extra Stiff Wire GuideDQX2022-02-17
3251851011428232K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy NeedleFCG2021-05-20
3251851013847114K183413TruWave Disposable Pressure TransducerDXO2019-05-01
3251851681966920K183399BD Nexiva Closed IV Catheter SystemFOZ2019-03-20
3251851267447659K183394CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiOCCK2019-05-01
3251851976337198K183036Dilator SetsDRE2018-12-20
3251851224025786K182403Peel-Away IntroducerFED2019-05-29
3251852056981181K181624Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling LineCCK2019-03-22
3251851719834026K173685Peel-Away Introducer SetDYB2017-12-20
3251852030549227K173354BD Nexiva Diffusics Closed IV Catheter SystemsFOZ2017-12-15
3251851442604705K173289Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing CatheterDQO2017-11-15
3251851150158158K173035Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and SetsFGE2018-05-01
3251852010978344K172980Micropuncture Pedal Access SetDYB2018-05-03
3251851871723898K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cordsKNS2018-05-24
3251851815873529K172092Reprocessed Shavers/BursHRX2017-10-04
3251851476987058K171997Mandril Wire GuideDQX2018-03-30
3251851689925258K171988Performer Guiding SheathDYB2018-03-30
3251851959720029K171953Bard Mission Disposable Core Biopsy InstrumentKNW2017-09-14
3251851445692938K171897Approach CTO Microwire GuideDQX2017-08-21
3251851056573998K171764Fixed Core Wire GuidesDQX2018-03-09
3251851094314960K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterFGE2017-10-13
3251851391724926K170020Peel-Away Introducer SetDYB2017-09-28
3251851908627887K161719Salter Labs Bubble HumidifierBTT2017-09-21
3251851061869529K160200Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter SetBWC2017-02-17
3251851401387076K153571Cavilon Advanced High Endurance Skin ProtectantKMF2016-08-23
3251851961863358K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesCCK2016-03-10
3251851698847592K151165Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureGAR2016-02-17
3251851935525197K143700CPAP CannulaideBZD2015-08-05
3251852005894132K143145SafeAir Smoke PencilGEI2014-12-04
3251851630965252K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer IntroducerDYB2015-07-28
3251851738916867K141495TRUWAVE DISPOSABLE PRESSURE TRANSDUCERDXO2014-09-03
3251851386117953K140085UNIVERSA PERCULTANEOUS DRAINAGE CATHETERFEW2014-11-18
3251851724807367K133948BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENTKNW2014-02-21
3251851237258947K133806M1 CAPNOGRAPHY MASKCCK2013-12-31
3251851353029325K131224SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSUREGAW2013-05-16
3251851265031215K123527AIRLIFECAF2013-04-25
3251851807569048K120125SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUFDXQ2012-10-03
3251851233374322K113542SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)BTT2012-02-10
3251851077617680K111640PRECISION FLOW(R) - HELIOXBTT2011-10-07
3251851705769110K110742ONESTEP ADULT MULTI-FUNCTION ELECTRODEMKJ2011-04-13
3251851246453845K102666KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIMKKX2010-11-09
3251851832137335K102520BD NEXIVA CLOSED IV CATHETER SYSTEMFOZ2011-01-06
3251852010857167K101688EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004KKX2010-09-20
3251851441274889K083641BIVONA TRACHEOSTOMY TUBESJOH2009-02-23
3251851477113412K083234KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100KKX2009-03-25
3251851280242101K080795ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWNFYA2008-09-03
3251851997000867K072845PRECISION FLOWBTT2008-07-17
3251851782239698K070876STRYKER TWIST DRILLSHBE2007-04-27
3251851148664819K070414GAMBRO CARTRIDGE BLOOD SETSFJK2007-10-12
3251851186091555K070060WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)DXQ2007-12-18
3251851616516726K063485LOGIC LAPAROSCOPIC SCISSORSGEI2006-12-01
3251851059589808K060623SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPEFER2006-09-06
3251852011519207K051367PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000MHX2005-06-20
3251851510043922K051092DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACCCCL2005-05-25
3251851236418430K051076ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODESMKJ2005-05-13
3251851507604613K043203WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBEKNT2005-05-11
3251851503894237K042410BAXJECT IILHI2004-10-08
3251851785215077K033754TRACER METRO SMART WIRE GUIDEOCY2003-12-30
3251851605923822K032840ATRION MEDICAL QL INFLATION DEVICEKOE2004-03-03
3251851033860276K024050COOK NEPHROSTOMY DILATION BALLOON CATHETER SETLJE2003-02-27
3251851054624352K024010DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETEREZL2003-06-11
3251851953001022K020304DISPOSABLE LIGHT HANDLE AND ADAPTORFTA2002-02-14
3251851361647130K010052RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZERMQM2001-03-19
3251851624479153K002768ACAPELLABWF2000-12-05
3251851254237652K001858OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITEKKX2000-08-17
3251851293231227K001545PIPET CURETHHK2000-06-15
3251851012212511
3251851019794714
3251851026739505
3251851028721984
3251851039304650
3251851044649774
3251851089383762
3251851098487493
3251851101826821
3251851118897914
3251851120149237
3251851147834134
3251851153428880
3251851157308193
3251851158359434
3251851167610609
3251851194444180
3251851195598723
3251851205131806
3251851216050995
3251851257907251

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB62024-03-25
KKX52010-11-09
DQX42022-02-17
CCK42019-05-01
BTT42017-09-21
KMF42016-08-23
FOZ32019-03-20
MKJ32017-12-27
JOH32009-02-23
DXO22019-05-01
FGE22018-05-01
DQO22017-11-15
KNW22017-09-14
GEI22014-12-04
CAF22013-04-25
DXQ22012-10-03
CAH21999-04-30
DRX21990-10-31
PTI12024-11-27
JKA12023-03-10
FMK12022-12-16
FMF12022-10-11
FCG12021-05-20
FED12019-05-29
DRE12018-12-20
KNS12018-05-24
HRX12017-10-04
BWC12017-02-17
GAR12016-02-17
BZD12015-08-05
FEW12014-11-18
GAW12013-05-16
FYA12008-09-03
FJK12007-10-12
HBE12007-04-27
FER12006-09-06
MHX12005-06-20
CCL12005-05-25
KNT12005-05-11
LHI12004-10-08