FDA.reportPublic FDA data

Synergy Health Ede BV

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30093374013009337401Synergy Health Ede BV1N2027-01-01Faunalaan38 Venlo Limburg NL 5928RZ
30097563273002807038Synergy Health Ede BV1N2027-01-01Morsestraat 3 Ede Gelderland NL GLD 6716AH
30209763543020976354Synergy Health Ede BV1N2027-01-01Faunalaan 46 Venlo Limburg NL 5928 RZ

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1526042032662275P990004SURGIFOAM ABSORBABLE GELATIN SPONGE, USPLMF1999-09-30
1526041137144977K980210VARIOUS SURGICAL OR PATIENT DRAPESKKX1998-05-15
1503711566983083K970073BIO-ESTHETIC INDIRECT ABUTMENTNHA1997-07-03
1503712009469752K961728MIRUSCONE ABUTMENT SYSTEMNHA1996-07-10
1503711526231933K955372BALL ATTACHMENT SYSTEMDZE1996-01-23
1503711868972300K911592STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANTDZE1993-07-22
1526041841019863K882724MICROTEK PROBE DRAPEKKX1988-08-03
1503711151812402K181958MagnetOs PuttyMQV2018-12-06
1503711169132268K181799ResCUBE™ Ligament Fixation SystemOWI2018-08-29
1503711208274128K171563MagnetOs PuttyMQV2017-08-24
1526041929603184K163005TIGR Matrix Surgical MeshOWT2017-07-27
1503712030140609K161859MagnetOsMQV2017-02-24
1526041852551332K161688Advanced Gynecological ApplicatorJAQ2017-01-27
1503711284260614K160797FMX314 Surgical PlatformOTJ2016-08-26
1526041994958423K160591D.O.R.C. Disposable Cryo ProbeHRN2017-01-23
1526041532334068K152684Nerve Capping DeviceJXI2016-01-13
1526041733796143K141816HEMOPORELYA2014-10-23
1526041565608664K141423NASOPORE-FDLYA2014-08-07
1526041978387623K140803LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMJAQ2014-06-26
1526041988300964K132874LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CMJAQ2014-02-21
1503711179355137K113836BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)FRO2012-09-24
1526041898193581K112267NEUROLAC(R) NERVE GUIDEJXI2011-10-20
1526041087875040K092224TIGR SURGICAL MESH , MODEL WK-6FTL2010-01-25
1503711009994795K083142PICASSO LASER SYSTEMGEX2009-03-13
1526041871968699K070715NASOPORE EARNHB2007-05-07
1526041564132860K062540NASOPORE EAR, MODELS ND04, ND05KCN2006-10-18
1503711365425068K061003SFB & CFB IMPLANTSDZE2006-06-30
1526041235190077K052099NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZLYA2005-11-21
1526041725564073K050573NEUROLAC NERVE GUIDEJXI2005-05-04
1503712039533778K050444NOBELREPLACE ADAPTER, MODEL 32412NHA2005-07-07
1526041715605289K050322MICROTEK EQUIPMENT DRAPESKKX2005-05-17
1526041948678830K042811VIVOSORB SHEET, MODEL FS01FTL2004-11-08
1503711870033288K041661NOBEL BIOCARE ENDOSSEOUS IMPLANTSDZE2004-08-26
1526042002922380K041237ECHOSAMPLERHFF2004-09-08
1526041135283951K032115NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03JXI2003-10-10
1503711063613977K030685TEETH IN AN HOUR - ARK IMPLANT CONCEPTDZE2004-02-06
1503711657032731K030257NOBEL PERFECT IMPLANT SYSTEMDZE2003-02-10
1503711038224833K023113REPLACE TIUNITE ENDOSSEOUS IMPLANTDZE2002-09-26
1526041040821143K013497FAS SET #4551MQE2001-11-09
1503711876175725K013483INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KITKOD2002-01-14
1503711614070174
1503711808618181
1526041947696727
1526041960928444
1526041006248669
1503711006248669
1503711013015055
1503711016037985
1526041018393793
1503711025980679
2968571033875235
1503711039408975
1503711039873850
1503711040821143
1503711049472255
1503711049615976
2968571049615976
1503711052002435
1503711059011521
1503711069995788
1503711080174542
1503711082057999
1503711082241876
1503711084722512
1526041084975242
1503711087005977
1526041090304144
1503711122795561
1526041140786376
1526041149953083
1503711151170525
1503711153641221
1503711155456988
1503711169132268
1526041174105684
1503711177527017
1526041180798495
1503711185290572
1526041188475430
1503711193613249
1526041211088352
1526041212019309
1503711212534070
1503711214376164
1503711215994079
1503711219218404
1503711227962630
1526041233126769
1526041242478935
1526041244144192
1503711250140159
1503711257065642
1526041265306741
1526041281037408
1503711289830745
1526041291673523
1526041299717143
1526041302579576
1503711306181096
1526041309646042
1526041311661992
1503711324281347
1503711329597137
1503711336969468
2968571338440689
1503711344421155
1503711346660597
1526041358065327
1526041373730833
1503711375351884
1526041376815594
1526041378501332
2968571378501332
1503711387050654
1526041399671916
1526041400816057
1526041403563763
1503711404200412
1503711404939395
1526041407438341

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE72006-06-30
JXI42016-01-13
MQV32018-12-06
JAQ32017-01-27
LYA32014-10-23
NHA32005-07-07
KKX32005-05-17
FTL22010-01-25
OWI12018-08-29
OWT12017-07-27
HRN12017-01-23
OTJ12016-08-26
FRO12012-09-24
GEX12009-03-13
NHB12007-05-07
KCN12006-10-18
HFF12004-09-08
KOD12002-01-14
MQE12001-11-09
LMF11999-09-30