FDA.reportPublic FDA data

STERIS Laboratories

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21838282183828STERIS Laboratories1N2026-01-019303 West Broadway Ave. Brooklyn Park MN US 55445

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2014231102041546P980031INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTSLQE1999-04-09
2014231090575799P950002BAK INTERBODY FUSION SYSTEMMAX1996-09-20
2014231718861183K894038PLUME-AWAY SMOKE EVACUATION SYSTEMFYD1989-09-28
2014231157031467K192239WavelinQ Plus EndoAVF SystemPQK2019-10-17
2014231124497613K182796WavelinQ 4F EndoAVF SystemPQK2019-02-06
2014231670963651K152441KIRO SetLHI2015-12-04
2014231011954491K151998TraceIT Tissue Marker - 3mLNEU2015-08-19
2014231618910533K151154FIBERGRAFT BG MorselsMQV2015-11-10
2014231841953001K151146N-Force Fixation SystemHWC2015-07-24
2014231606001643K150400Renu GelMIX2015-04-06
2014231638102791K143533FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTEMQV2015-03-25
2014232035227310K141956FIBERGRAFT BG MORSELSMQV2014-08-13
2014231069938853K133697BREAST-MED TISSUE MARKERNEU2015-04-10
2014231064145153K132805BG MORSELSMQV2014-03-14
2014231026470468K132244N-FORCE FIXATION SYSTEMHWC2014-03-06
2014231413364247K122733V2F ANTERIOR FIXATION SYSTEMKWQ2012-12-07
2014231311987062K122637LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999FST2012-11-01
2014231041050866K121964MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10MLNEU2013-01-23
2014231598125496K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTMIX2013-02-22
2014231005559898K112794EOS SMALL BONE FIXATION SYSTEMHRS2012-05-10
2014231077585600K111796INVIZIA ANTERIOR CERVICAL PLATE SYSTEMKWQ2011-10-27
2014231212857890K080367ZIMMER MIS LIGHTFST2008-02-22
2014232029685119K063560HILGER DUAL-STIM NERVE STIMULATORETN2007-01-05
2014231073358219K061353TRINICA ANTERIOR LUMBAR PLATE SYSTEMKWQ2006-08-30
2014231244841698K052970SIMPLICI-T ANNULOPLASTY SYSTEMKRH2006-01-11
2014231961763611K040262DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIXMQV2005-03-17
2014231202506446
2014231332730772
2014231376852367
2014231377699334
2014231657570328
2014231807513566
2014231867064777
2014231198635291
2014231282243194
2014231351553458
2014231387665911
2014231407316668
2014231412755399
2014231465706791
2014231517152950
2014231673867309
2014231849100252

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQV52015-11-10
NEU32015-08-19
KWQ32012-12-07
PQK22019-10-17
HWC22015-07-24
MIX22015-04-06
FST22012-11-01
LHI12015-12-04
HRS12012-05-10
ETN12007-01-05
KRH12006-01-11
LQE11999-04-09
MAX 11996-09-20
FYD11989-09-28