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Dsm-Biomedical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25301541000307073DSM Biomedical, Inc.1N2026-01-01735 Pennsylvania Dr EXTON PA US 19341

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
508821562331081K993166STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEMHWC2000-08-04
508821399341227K973789NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CCGXP1998-05-18
508821988688895K940643OSMED EPI-GUIDELYC1996-10-15
508822060813079K230054DSM Biomedical Calcium Phosphate CementMQV2023-03-21
508821102519867K193212DSM Biomedical Dental Bone Graft PlusNPM2020-09-10
508821611814027K173572DSM Biomedical Calcium Phosphate Cement with MicrospheresMQV2018-05-09
508821057550831K173362DSM Biomedical Calcium Phosphate CementMQV2018-04-03
508821111907579K170245DSM Biomedical Dental Bone GraftNPM2017-05-16
508822028579704K160474DSM Biomedical Porcine Pericardium Dental MembraneNPL2016-06-07
508821383746376K152636Laser DockGEX2015-12-17
508821809677019K143716DSM Biomedical DPR CableJDQ2015-10-29
508821728353896K141738MEDEOR MATRIX WOUND DRESSINGKGN2015-02-17
508821791240730K140855ARTHREX SUTURETAK SUTURE ANCHORSMAI2014-12-18
508821976252847K133169MESO TENDON MATRIXOWY2013-12-20
508821944820850K132025MESO BILAYER SURGICAL MESHFTM2013-10-30
508821991089927K122489EMERGE MEDICAL SOLID BONE SCREWSHWC2012-12-10
508821046842922K121310MESOTHELIUM DENTAL MEMBRANENPL2013-07-11
508821769098182K120141KENSEY NASH BONE VOID FILLER XCMQV2012-05-04
508821058550031K112888MESO WOUND MATRIXKGN2012-02-10
508821488385700K112040ARTHREX BIOCOMPOSITE TRANSFIXMAI2011-12-15
508821100013022K103787MEDEOR MATRIXFTM2011-02-07
508821089480921K103558SYNTHES SCOUT VESSEL GUARDOMR2011-02-18
508821011587114K102018NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTYGXP2010-09-23
508821799613106K100992NEURALMASETN2010-09-24
508821396495227K094061KENSEY NASH ECM SURGICAL PATCHFTM2010-05-18
508821277557514K093464RAPIDSORB PLUS SCREW SYSTEMDZL2010-01-25
508821171640142K091499MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)FTM2009-10-22
508821688613047K091192KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XXNPL2009-11-02
508821417348474K090919KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANENPL2009-10-02
508821038078583K081439VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTEMQV2008-06-17
508821784661153K073303NORIAN DRILLABLEOIS2008-07-02
508821235259616K072384MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTEMQV2007-09-21
508821646499049K071456ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANTMAI2008-01-17
508821418525896K071237COPIOS BONE VOID FILLER SPONGE AND PASTEMQV2007-06-01
508821774875354K060445NORIAN CRS BONE CEMENTGXP2006-04-13
508821077468300K060408NORIAN SRS BONE VOID FILLERMQV2006-03-21
508822009639370K060406NORIAN SRS FAST SET PUTTYMQV2006-03-20
508821681917017K051611MBARESORB IMPLANTHWC2005-09-06
508821733174341K050259ARTHREX BIO-PINHTY2005-05-27
508821690527695K043259BIOBLANKET SURGICAL MESHFTM2005-08-15
508821812200546K043145BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367BHTN2005-02-18
508821774143847K041842NORIAN SRS FAST SET PUTTYMQV2004-07-23
508821417778794K033679COPSIOS BONE VOID FILLER (BVF)MQV2004-07-07
508821671525642K033252MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEMHWC2003-11-13
508821751494918K011897NORIAN SRS BONE VOID FILLERMQV2001-12-20
508822062099421K003338BIO-EYE II ORBITAL IMPLANTHPZ2001-02-07
508821837823060K000506BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324BMAI2000-05-01
508821477366339BK140176
508821520788390BK130053
508821240528678
508821658737631
508821749669399
508821863611397
508821007007315
508821012847431
508821030222867
508821038078583
508821052401459
508821096530822
508821119938164
508821140365819
508821170274939
508821196436526
508821266153093
508821275296292
508821290377492
508821315555409
508821345433267
508821377566317
508821387395032
508821421265471
508821435693425
508821476300723
508821574796749
508821639111322
508821639674989
508821662276867
508821696358564
508821717905968
508821745602181
508821769961948
508821784286333
508821833076813
508821845197013
508821895934507
508821923744835
508821928335643
508821996670143
508822006809721
508822009414242
508822024005769

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQV122023-03-21
FTM52013-10-30
NPL42016-06-07
MAI42014-12-18
HWC42012-12-10
GXP32010-09-23
NPM22020-09-10
KGN22015-02-17
GEX12015-12-17
JDQ12015-10-29
OWY12013-12-20
OMR12011-02-18
ETN12010-09-24
DZL12010-01-25
OIS12008-07-02
HTY12005-05-27
HTN12005-02-18
HPZ12001-02-07
LYC11996-10-15

PMN#

GUDID#

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