FDA.reportPublic FDA data

SYNERGY HEALTH STERILISATION UK LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028073153002807315SYNERGY HEALTH STERILISATION UK LTD1N2026-01-01Drayton Fields Industrial Estate Brunel Close Daventry Northamptonshire GB NN11 8RB
30101321113010132111Synergy Health Sterilisation UK Ltd1N2026-01-01Moray Road Elgin Industrial Estate Swindon Wiltshire GB SN2 8XS

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1474191400424144P990020ANEURX STENT GRAFT SYSTEMMIH1999-09-28
1474191141260936P790017USCI DILATATION CATHETERLOX1980-03-24
1474191709953637P110011ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEMNIO2011-10-26
1474191714001408P100040VALIANT THORACIC STENT GRAFT SYSTEMMIH2011-04-01
1474191755528547P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMIH2010-12-16
1474192019214116P090006COMPLETE SE VASCULAR STENT SYSTEMNIO2010-03-17
1474191349887898P070027THE TALENT ABDOMINAL STENT GRAFT SYSTEMMIH2008-04-15
1474191093963874P070007TALENT THORACIC STENT GRAFT SYSTEMMIH2008-06-05
1474251073911130P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
1474251416170545K994166GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODEKNS1999-12-27
1474251137024546K993749GYRUS HYSTEROSCOPIC RESECTOSCOPEHIH1999-12-03
1474251797308974K993238FORTOSS-CEMALYC2000-01-14
1474251892091392K992901GYNECARE VERSAPOINT G-VAP ELECTRODEHIH2000-01-18
1474251368596058K992876VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEMHRX1999-09-24
1474251907028450K992556PERMACOLFTL2000-02-17
1474251943039362K992406VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEMGEI1999-08-06
1474251104312688K991261ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPETMQH1999-08-05
1474191642734127K990910MTP HAMOU ENDOMAT DISPOSABLE TUBING SETSHIH1999-06-03
1474251714532477K990628GYRUS ENDOUROLOGY SYSTEMKNS1999-06-29
1474251260924400K982771GYRUS HYSTEROSCOPIC RESECTOSCOPEHIH1999-01-21
1474251030746414K982738VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH1999-03-01
1474251537820524K974022VAPRGEI1998-01-12
1474191548006281K973899UNIFINE PENTIPSFMI1997-12-04
1474251155321417K963783MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USEGEI1996-11-25
1474252035883531K9551033M NO STING BARRIER FILMKMF1996-02-05
1474192035883531K9551033M NO STING BARRIER FILMKMF1996-02-05
1474251205192088K913461FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEMJDR1991-10-15
1474251545351987K912245AGC REVISION KNEE PROTHESISJWH1991-08-19
1474191635666970K871571NEUROTIPS(TM)GXB1987-06-18
1474252011390473K864938'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTORLRC1987-03-23
1474251899382757K833921AGC TOTAL KNEE PROSTHESISJWH1984-01-31
1474252025667933K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadLPH2019-11-05
1474251033996898K180243Infinity-Lock Button SystemHTN2018-04-03
1474191345924136K173110GRAFTSITEBSP2018-05-18
1474191955619143K170388ANCHORMAN Tibial Ligament Fixation DeviceMBI2017-07-25
1474251628842823K152206SurgiPure XD Reconstructive Tissue MatrixFTM2016-03-08
1474191706231903K151601SECURE-LOOPMBI2015-09-09
1474251706231903K151601SECURE-LOOPMBI2015-09-09
1474191421294873K1512532cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterPNO2015-06-10
1474252035441659K143475VAPR Tripolar Suction ElectrodeGEI2015-04-03
1474192002695571K1428685mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pinGEI2014-11-21
1474251444554864K140896VAPR ARCTIC SUCTION ELECTRODEGEI2014-08-05
1474251551884108K133257BIOPSY PIPETTESMQH2014-05-16
1474191154405532K130734SAUFLON MULTIPURPOSE SOLUTIONLPN2013-05-15
1474251425224735K122605PKS BILLHIN2012-12-05
1474251008020855K122565ARC ENDOCUFFFED2012-09-04
1474192030705189K122446LIQUIDBAND FLOW CONTROLMPN2012-10-26
1474251523939476K122425VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECTGEI2012-11-05
1474251607921100K121149VANGUARD SSK 360 REVISION KNEE SYSTEMJWH2012-05-16
1474251420770601K120605PERMACOL SURGICAL IMPLANTFTM2012-05-18
1474251313439351K120095SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HANDGEI2012-04-06
1474251119481599K113545VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HANGEI2012-02-27
1474251562581336K112413RI MSC (MIGRATION SEDIMENTATION CHAMBER)MQK2012-07-13
1474252052885093K111751VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSHIN2011-12-02
1474252072331961K100816PK SUPERPULSE SYSEM GENERATOR MODEL 744000GEI2010-07-01
1474191438529006K100803OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1FEQ2010-04-22
1474251338611704K100638VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214GEI2010-06-18
1474191184978769K093471KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMPHRX2010-10-18
1474252032604841K093293VANGUARD 360 REVISION KNEE SYSTEMJWH2010-10-22
1474251276345269K093181GYRUS ACMI PK BUTTON ELECTRODEFAS2010-02-24
1474251037108487K092712SKIN BARRIER FILMKMF2010-02-23
1474251264176331K0826433.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATEGEI2008-12-19
1474252026777853K082575ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTESMQV2008-11-25
1474191223929131K082491OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENEMTJ2008-09-24
1474251768842920K082383FORTOSS VITALLYC2008-09-05
1474251234762190K081428MODIFICATION TO DOUBLEPLAY SUTURE ANCHORHWC2008-06-20
1474191355087702K080736ACTIFUSE SHAPE BONE GRAFT SUBSTITUTEMQV2008-04-16
1474252002592126K072127DOMINATORHWC2007-08-31
1474251747307973K071952GRAFTLOCK SCREW, ST SCREWHWC2007-08-14
1474191426967409K071887SPORTMESH OR ARTELON TISSUE REINFORCEMENTFTL2007-09-18
1474251411430408K071791MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280GXP2007-07-30
1474251814748417K071776ANEUROPLASTIC, MODEL 43-1290JXH2007-07-26
1474251975336920K071442SUPRASORB A +AGFRO2008-05-01
1474251332194880K071206ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTEMQV2007-05-31
1474251225570948K071115MODIFICATION TO BILOK ST SCREWHWC2007-05-17
1474251645298760K071091MODIFICATION TO BILOK SCREWHWC2007-05-17
1474191868078081K061956ARTELON STT SPACERKYI2007-06-07
1474191989472210K061954ARTELON CMC SPACER ARTHROKYI2007-06-01
1474251360565011K061949DOUBLEPLAY SUTURE ANCHORHWC2006-09-25
1474251896703620K061311ALLOGRAN-RMQV2006-09-22
1474251191337287K053562ZIMMER COLLAGEN REPAIR PATCHFTM2006-06-23
1474251841413530K050355PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150PAI2005-03-09
1474251045881471K043514ALLOGRAN-N-BONE VOID FILLERMQV2005-01-21
1474251785432149K043366PERMACOL SURGICAL IMPLANTFTL2004-12-17
1474251317672360K041135VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODESHRX2004-05-10
1474251034435673K040600GENEX BONE GRAFT SUBSTITUTEMQV2004-05-07
1474251657820936K040302VERSAPOINT RESECTOSCOPIC SYSTEMHIH2004-03-09
1474251573818769K040082PORE-SI BONE GRAFT SUBSTITUTEMQV2004-08-04
1474191056682947K040070ARTELON SPACER CMC-1KYI2004-09-21
1474191745792869K033842NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUEGCJ2004-03-04
1474252069747956K031085GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)GEI2003-07-21
1474191648503872K030278SAUFLON MULTIPURPOSE SOLUTION - NO RUBLPN2003-07-30
1474191188675357K024097SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14CAC2003-02-14
1474251736793465K023960LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70DXG2003-01-09
1474191528476030K022489SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514CAC2002-10-09
1474191803938268K022477SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SETCAK2002-10-25
1474251609864916K021551STIMULAN - CALCIUM SULFATE BONE VOID FILLER KITMQV2002-11-01
1474251936462887K021351BIOSTEON CROSS PINHWC2002-10-17
1474251699704918K021056PERMACOLFTM2002-10-31
1474251822963925K013625PERMACOLFTM2002-01-17
1474252014247335K012551LIVERPOOL RADIAL HEAD REPLACEMENT DEVICEKWI2002-01-30
1474251500431146K011138OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENTHRY2001-07-10
1474191613108577K010559SAUFLON MULTI LENS CARE SYSTEMLPN2001-12-20
1474191198033700K010051POLY-TAPES WITH THE FASTLOK FIXATION DEVICEJDR2001-07-13
1474251198033700K010051POLY-TAPES WITH THE FASTLOK FIXATION DEVICEJDR2001-07-13
1474251922774364K002422VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEMGEI2000-08-31
1474251266064423K002402VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEMHRX2000-08-31
1474191941431847K002172POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)GAT2001-08-28
1474251941431847K002172POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)GAT2001-08-28
1474251280206370K001724STIMULAN -CALCIUM SULFATE BONE VOID FILTERMQV2000-08-04
1474251546891626K001270GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODEFJL2000-04-28
1474251928832680K000936VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEMGEI2000-04-19
1474191028324042
1474191058053767
1474191231874245
1474191246130863
1474191257876635
1474191391470340
1474251493056726
1474251535036979

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI152015-04-03
MQV92008-11-25
HWC72008-06-20
HIH62004-03-09
FTM52016-03-08
JWH42012-05-16
HRX42010-10-18
MBI32017-07-25
LPN32013-05-15
MIH32011-04-01
KMF32010-02-23
FTL32007-09-18
KYI32007-06-07
JDR32001-07-13
MQH22014-05-16
HIN22012-12-05
NIO22011-10-26
LYC22008-09-05
CAC22003-02-14
GAT22001-08-28
KNS21999-12-27
LPH12019-11-05
BSP12018-05-18
HTN12018-04-03
PNO12015-06-10
MPN12012-10-26
FED12012-09-04
MQK12012-07-13
FEQ12010-04-22
FAS12010-02-24
MTJ12008-09-24
FRO12008-05-01
GXP12007-07-30
JXH12007-07-26
PAI12005-03-09
NRA12004-04-21
GCJ12004-03-04
DXG12003-01-09
CAK12002-10-25
KWI12002-01-30