FDA.reportPublic FDA data

Sterigenics Germany GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028070903006003617Sterigenics Germany GmbH1N2026-01-01Kasteler Stra�e 45 Wiesbaden Hesse DE D-65203

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1107382048666300P830063GAMBRO FIBER PLASMAFILTERMDP1986-05-27
1107381857825492P170042Covera™ Vascular Covered StentPFV2018-07-30
1107381581272270P130029FLUENCY PLUS ENDOVASCULAR STENT GRAFTPFV2014-06-17
1107381064832491P080007BARD E-LUMINEXX VASCULAR STENTNIO2008-12-04
1107381404589030P070014LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEMNIP2009-02-13
1107381305010062K993239STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXXHAW2000-01-18
1107381176126582K982629DORNIER MEDILAS DGEX1998-09-14
1107382047334339K972135MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SETFPA1997-08-26
1107381073216563K971244PROVOX 2 VOICE PROSTHESIS SYSTEMEWL1997-06-06
1107381139143777K940638PROVOX(TM) VOICE PROSTHESISEWL1994-06-22
1107381010896882K190766PALACOS fast R+GLOD2019-05-31
1107381472272950K182260PALACOS MVLOD2018-09-17
1107381682566485K181486DEKA Motus AYGEX2018-08-30
1107381949164311K173879MiniMed Mio Advance infusion setFPA2018-03-05
1107381787094833K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording ModuleHIH2018-01-04
1107381824367786K162929Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask TrackerHAW2017-02-22
1107381812420246K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion SetFPA2017-11-01
1107381729174683K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemKNW2016-08-02
1107381105322191K160693Neptune E-SEP Smoke Evacuation PencilGEI2016-04-13
1107381911843557K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®FPA2016-08-10
1107381068494330K153679Stryker Neptune E-SEP Smoke Evacuation PencilGEI2016-01-22
1107381835228837K151317Armada 18 PTA CatheterLIT2015-07-06
1107381105949249K151139EasyMap MAP CatheterDRF2016-10-18
1107381232109321K143145SafeAir Smoke PencilGEI2014-12-04
1107381569924634K141941SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES DOLO2014-10-31
1107381356344918K141432NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSHDTN2014-07-07
1107381884331021K140569ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)DWF2014-11-19
1107381920365268K133265QUADROX-IR ADULT AND SMALL ADULTKFM2013-11-12
1107381728774094K132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSDTZ2013-10-08
1107381071872028K132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTDTN2013-10-30
1107382026199795K131947PROVOX VEGA PUNCTURE SETEWL2013-10-18
1107381217200377K131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGDWF2013-07-05
1107381370991368K130827FIRMAP CATHETERMTD2013-10-31
1107381824434806K130792LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEMFGE2013-08-30
1107381048170459K130639ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETERDWF2013-05-16
1107381693554800K123288HEMOCONCENTRATORKDI2013-06-26
1107381011757659K123035SEAL ONEDXC2012-11-28
1107381004094049K121426AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPSGEI2012-07-10
1107381566527119K121031WAVELIGHT FS200 PATIENT INTERFACE 1505GEX2012-06-21
1107381737786583K120872ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPSFPA2012-04-20
1107381458513479K110924DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPSGEI2011-12-07
1107381553392487K102990BRAINLAB KNEEOLO2011-04-04
1107381444434125K102705ARMADA 14 PTA CATHETERLIT2010-12-07
1107381723296774K100451GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132MPB2010-12-21
1107381636270326K100038DISPOSABLE REFLECTIVE MARKER SPHERESHAW2010-07-14
1107381207579237K092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)EWL2010-10-14
1107381494331761K092467VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITEDHAW2010-05-06
1107381984265810K090832RAPID-IMQK2009-12-23
1107382023102096K090455PROVOX VEGA, MODEL 8130-8135EWL2009-06-05
1107381113503822K082755SEDAT FLAMINGOMAV2008-12-15
1107381987486930K080472SEDAT MYSHELL LITEDTL2008-04-23
1107381297044264K073260LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109DTL2008-03-13
1107381240333890K071330GALTSTICK INTRODUCER SYSTEMDRE2007-10-31
1107381570884989K070106VV FLUORO 3DHAW2007-04-23
1107381878808010K063532BARD E LUMINEXX BILIARY STENTFGE2008-05-30
1107381303308610K062640STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000HAW2006-12-14
1107382001695130K060808BRAINPRO, BRAINPRO ACCESSHAW2006-07-25
1107381925262895K060487LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEMFGE2006-03-23
1107382008004527K053404LIFESTENT FLEXSTART BILIARY STENT SYSTEMFGE2005-12-21
1107381026538855K050855PALAMED GLOD2005-07-07
1107381829609674K050854PALACOS LV+GLOD2005-07-07
1107381202038503K050832FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTJCT2005-07-07
1107381131155065K042449DOLPHIN INFLATION DEVICEMAV2005-04-18
1107381029429597K040301GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX AMPB2004-11-01
1107381737681506K031673REFOBACIN -PALACOS GLOD2004-05-25
1107381113422599K031186LUMINEXX ENDOSCOPIC BILIARY STENTFGE2003-05-06
1107381404334292K030904PALAMEDLOD2003-09-23
1107381744929918K030903OSTEOPALLOD2003-09-23
1107381424298096K030902PALACOS RLOD2003-09-23
1107381196659576K020220ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTELFL2002-08-23
1107381009832186
1107381044464235
1107381275311069
1107381481435905
1107381559448063
1107381565282441
1107381713746625
1107381856511716
1107381982221930
1107381004094049
1107381005307737
1107381012606987
1107381012754900
1107381029135914
1107381064832491
1107381080554646
1107381113422599
1107381116263879
1107381144176134
1107381146741570
1107381159806311
1107381182437940
1107381194466974
1107381217200377
1107381223966016
1107381294614755
1107381302435559
1107381305010062
1107381355350404
1107381404589030
1107381433754900
1107381439254499
1107381444434125
1107381454765963
1107381458513479
1107381470761885
1107381482857467
1107381492651751
1107381532908569
1107381543611499
1107381544926873
1107381547133705
1107381551116295
1107381558335798
1107381569399865
1107381569924634
1107381581272270
1107381592078747
1107381592462405
1107381625218079

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOD82019-05-31
HAW72017-02-22
FPA52018-03-05
GEI52016-04-13
EWL52013-10-18
FGE52013-08-30
GEX32018-08-30
DWF32014-11-19
PFV22018-07-30
LIT22015-07-06
OLO22014-10-31
DTN22014-07-07
MPB22010-12-21
MAV22008-12-15
DTL22008-04-23
HIH12018-01-04
DRF12016-10-18
KNW12016-08-02
KFM12013-11-12
MTD12013-10-31
DTZ12013-10-08
KDI12013-06-26
DXC12012-11-28
MQK12009-12-23
NIP12009-02-13
NIO12008-12-04
DRE12007-10-31
JCT12005-07-07
LFL12002-08-23
MDP11986-05-27