FDA.reportPublic FDA data

Synergy Health Radeberg GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30081020423002924544Synergy Health Radeberg GMBH1N2027-01-01Juri-Gagarin-Strasse 15 Radeberg Saxony DE 01454

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2013281512425236K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemHSB2018-06-06
2013282027692993K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemHSB2018-01-12
2013281866998207K171982DROPLET PEN NEEDLEFMI2018-03-21
2013281556210611K170988DropSafe Safety Pen NeedleFMI2017-12-12
2013281807766756K161351NanoBone SBX PuttyMQV2016-10-26
2013282025403260K143437Droplet Pen NeedlesFMI2015-06-25
2013282070447127K141189NANOBONE / GRANULATEMQV2015-01-30
2013281919782906K131365T2 TIBIAL NAILING SYSTEMHSB2013-10-10
2013281870464534K123356FORTIVA PORCINE DERMISFTM2013-03-05
2013281926626082K100334DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811KDI2010-04-22
2013282054732935K072808SPEEDICATH COMPACTGBM2007-11-09
2013282069721578K071984MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEMGWM2008-06-27
2013281718508264K071518DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERSKDI2007-08-17
2013281593136135K063025LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,GEI2006-12-01
2013281850875163K023254SPEEDICATHGBM2003-01-27
2013282068827403K020285CMA CEREBRAL TISSUE MONITORING SYSTEMGWM2002-10-23
2013281597801405
2013281808618181
2013281967695457
2013281006318107
2013281012772600
2013281021491469
2013281033544686
2013281033875235
2013281088475364
2013281092173471
2013281121485830
2013281135315591
2013281162612289
2013281171795805
2013281176807561
2013281188475430
2013281204362095
2013281212019309
2013281214356825
2013281216412145
2013281220341616
2013281253860177
2013281267050761
2013281271839604
2013281275885951
2013281307731316
2013281311797075
2013281314714635
2013281317666109
2013281326012245
2013281330459979
2013281367879326
2013281386764913
2013281397917716
2013281406361621
2013281425189017
2013281435038530
2013281446462649
2013281457216453
2013281458117670
2013281465548302
2013281468722492
2013281484710751
2013281493056726
2013281496307859
2013281502001455
2013281506688535
2013281506691093
2013281507575156
2013281529396819
2013281535172496
2013281537848903
2013281541134621
2013281545456078
2013281556210611
2013281583149900
2013281589344718
2013281593136135
2013281594239586
2013281597113959
2013281599854168
2013281634076283
2013281641261458
2013281648195959
2013281648320820
2013281676657948
2013281679719602
2013281686870451
2013281713242193
2013281713824590
2013281723176722
2013281735967656
2013281739113182
2013281742745979
2013281744562003
2013281747521784
2013281755871651
2013281759315841
2013281779539398
2013281781030759
2013281807466666
2013281815695865
2013281824208018
2013281866998207
2013281874687633
2013281878890894
2013281889154938
2013281893266338
2013281893855154
2013281943667148
2013281954735664
2013281958979661
2013281964012555
2013281971220825
2013281972816730
2013281974908616
2013281983975073
2013281984962617
2013282008139867
2013282029788036
2013282037662627
2013282037892379
2013282038014039
2013282039397639

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HSB32018-06-06
FMI32018-03-21
MQV22016-10-26
KDI22010-04-22
GWM22008-06-27
GBM22007-11-09
FTM12013-03-05
GEI12006-12-01