FDA.reportPublic FDA data

Michael van der Woude

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101413473010141347Michael van der Woude1N2026-01-012500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
00Michael van der Woude5N2020-04-252500 Bee Cave Road Bldg 1 Suite 300 Austin TX US 78746
00Michael van der Woude5N2020-04-252500 Bee Cave Road, Bldg 1, Suite 300 Austin TX US 78746
80102783008238476Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
80207764224Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
96144513001446177Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
96165871000546468Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
96803113010286024Michael van der Woude1N2020-04-252500 Bee Cave Road Building 1, Suite 300 Austin TX US 78746
97100613003346501Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
10002474591000247459Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30028073363002807336Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30030673783003067378Michael van der Woude1N2020-04-252500 Bee Cave Road, Building 1 Suite 300 Austin TX US 78746
30038511243003851124Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30040599353004059935Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30054019913005401991Michael Van Der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30061230983006123098Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30066174783006617478MICHAEL VAN DER WOUDE1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30067977833006797783Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30070846493007084649Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30089260933008926093Michael Van Der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30093075043009307504Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30094053533009405353Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30096011213009601121Michael van der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30096903133009690313Michael Van Der Woude1N2020-04-252500 Bee Cave Road, Bldg 1, Ste 300 Austin TX US 78746
30104508713010450871Michael Van Der Woude1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1054031986954209K991620VISINE FOR CONTACTSLPN1999-09-24
407622017973492K953829SAFE-T-SEALKCT1995-11-09
217481013775096K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsLZC2018-06-27
1410931050586535K172490eUnityLLZ2018-02-06
1557461148359330K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeITX2017-07-31
612251605208382K170050Z-CAD smileEIH2018-08-23
217481918575576K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)LZA2016-11-02
1410931044991343K161515eUnityLLZ2016-11-15
1557461929485824K161414Anatomic Total Knee SystemJWH2017-01-19
405041898065753K161177Axiom PXDZE2017-06-15
405041741961500K160730Instrument kitsKCT2017-04-27
1557461049509278K150765LDR Spine ROI-C Cervical Cage SystemOVE2015-09-17
1557461762584367K142645Avenue T TLIF CageOVD2015-06-11
217481821941021K142283Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)LZA2015-01-16
405041733292358K141450AXIOM 2.8DZE2014-09-17
405041248600046K131066AXIOM REGDZE2014-02-21
1425031520394613K130534DIPLOMATEIA2013-10-30
1557461226889331K121103LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT SNKB2012-08-24
405041889194876K121103LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT SNKB2012-08-24
251071686075807K120025SURGIMESH XB - SKIRTEDFTL2012-06-26
1557461541721066K113559LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTSODP2011-12-29
405041975003452K113559LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTSODP2011-12-29
1557461209150128K113285LDR SPINE USA AVENUE L INTERBODY FUSIONOVD2012-07-26
405041651230183K113285LDR SPINE USA AVENUE L INTERBODY FUSIONOVD2012-07-26
405042040782344K113270INSTINCT JAVA SYSTEMNKB2011-12-16
405041549611399K111532MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECEEGS2011-10-07
1410931015114224K111164EUNITYLLZ2011-05-06
217481138824842K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2011-04-15
405041894004816K110327LDR SPINE ROI-A INTERBODY FUSION SYSTEMOVD2011-09-30
405041327332325K102241ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNITEBW2011-03-23
405041470422688K101913ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOMDZE2011-03-11
1748701178574726K101705MISTRAL-AIR WARMING SYSTEMDWJ2010-07-02
1115391758156665K101596KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-LZC2010-07-21
405041138363653K093894ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEEFA2010-03-03
217481261648521K093523MICRO-TOUCH NITRILELZA2010-03-04
896661754335714K091393ELEKTA NEUROMAG WITH MAXFILTEROLX2010-10-26
1557461431204115K091088LDR SPINE CERVICAL INTERBODY FUSION SYSTEMODP2009-07-14
405041699711045K091088LDR SPINE CERVICAL INTERBODY FUSION SYSTEMODP2009-07-14
405041296822259K090676MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLESEFA2009-05-22
405041437719545K090507MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEMMAX2009-06-25
405041388009066K083857LDR SPINE ROI-C IMPLANTMQP2009-02-12
1557462047503983K083857LDR SPINE ROI-C IMPLANTMQP2009-02-12
405041848392273K082592LDR SPINE EASYSPINE SYSTEMNKB2008-10-08
405041324485141K082262LDR SPINE ROI INTERBODY FUSION SYSTEMMAX2009-02-02
1557462066891273K082262LDR SPINE ROI INTERBODY FUSION SYSTEMMAX2009-02-02
896661865783674K081430ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDINGOLX2008-07-28
217481521962143K081260KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVESLZA2008-07-09
1115391851095517K081089KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIMLZC2008-07-14
405041063543419K080728LDR SPINE ROI-C IMPLANTMQP2008-05-29
1557461675619779K080728LDR SPINE ROI-C IMPLANTMQP2008-05-29
405041516000615K080572LDR SPINE ROI-A IMPLANTMQP2008-04-07
1557461214551079K080569LDR SPINE ROI-T IMPLANTMQP2008-05-07
405041867219784K080569LDR SPINE ROI-T IMPLANTMQP2008-05-07
251071152262890K072974SURGIMESH XBFTL2008-08-18
612251772250318K072569METOXIT CAM-BLANKSEIH2007-10-31
405041356629846K072132LDR SPINE ROI-T SYSTEMMQP2007-08-30
1557461949374052K072132LDR SPINE ROI-T SYSTEMMQP2007-08-30
405041330693379K070341LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEMKWP2007-08-08
405041874110466K063794MODIFICATION TO EASYSPINE SYSTEMMNI2007-01-24
217481482225946K061553NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVESLZA2006-07-17
251071150852944K061445SURGIMESH WNFTL2007-02-01
405041648225480K061017EASYSPINE SYSTEMMNI2006-08-10
473631443228912K052665GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHESFRG2006-02-27
217481597510773K052502NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVESLZA2005-11-18
405041440145432K052037MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEMKTT2005-08-05
405042067018461K050048HOFFMAN II MICRO EXTERNAL FIXATION SYSTEMKTT2005-03-04
896662067157630K050035ELEKTA NEUROMAG WITH MAXWELL FILTEROLX2005-01-25
1557461358156954K043479MC+ PARTIAL VBRMQP2005-06-30
405041815218846K043479MC+ PARTIAL VBRMQP2005-06-30
1557461043349181K043349OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)MQP2005-06-29
405041914880037K043349OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)MQP2005-06-29
405041449606009K043094EASYSPINE SYSTEMMNI2005-02-11
405041251344761K042019HOFFMANN II MICRO EXTERNAL FIXATION SYSTEMKTT2004-09-24
896662052395117K041264ELEKTA OYOLX2004-08-10
405041191011524K040674IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLESEFA2004-06-30
217481885666405K032444NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPYLZC2003-11-13
217482033709968K031581NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROGLYY2003-07-24
217481912584571K031580NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVELZA2003-07-25
896661413586943K023864PERFORMA STEREOIZH2003-01-09
473631762734784K023025SELF SEAL STERILIZATION POUCHFRG2003-03-04
217481336856778K022765NITRILE POWDER-FREE EXAMINATION GLOVESLZA2002-10-11
405041586266057K020431FIBIOCOREELR2002-07-03
91371000798095
1186881002150546
91371012850578
473631064708112
405041096875745
473631134452699
587121154774994
896661174658392
91371220120960
1654891238810975
1425031241716861
91371290694331
896661343194687
174111360113205
91371411644293
174111421833864
548141464079793
1847261468334220
405041486148277
473631531010539
405041542060497
91371548031864
548141569476030
2307451576194372
1272811582437280
91371617123566
405041674468860
2562381676801542
896661677720686
473631684140575
405041686952883
405041686963818
174111695672715
473631708192933
2458861737052737
405041779508354
473631811056731
1425031859007157

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQP132009-02-12
LZA92016-11-02
LZC42018-06-27
DZE42017-06-15
OVD42015-06-11
NKB42012-08-24
ODP42011-12-29
OLX42010-10-26
LLZ32018-02-06
FTL32012-06-26
EFA32010-03-03
MAX32009-06-25
MNI32007-01-24
KTT32005-08-05
EIH22018-08-23
KCT22017-04-27
FRG22006-02-27
ITX12017-07-31
JWH12017-01-19
OVE12015-09-17
EIA12013-10-30
EGS12011-10-07
EBW12011-03-23
DWJ12010-07-02
KWP12007-08-08
LYY12003-07-24
IZH12003-01-09
ELR12002-07-03
LPN11999-09-24