FDA.reportPublic FDA data

STERILMED, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30112767733011276773STERILMED, INC.1N2026-01-015010 Cheshire Pkwy N Ste 2 Plymouth MN US 55446
21340703001237663STERILMED, INC.1N2020-04-2511400 73rd Ave N Ste 100 MAPLE GROVE MN US 55369

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10888551004312NA - BUR FLUTED BALL LEGEND SYSTEM+1(888)541-0078customerservice@sterilmed.com
10888551004312NA - BUR FLUTED BALL LEGEND SYSTEM+1(888)541-0078sterilmedcs@its.jnj.com
10888551004329NA - BUR DIAMOND BALL LEGEND SYSTEM+1(888)541-0078customerservice@sterilmed.com
10888551004329NA - BUR DIAMOND BALL LEGEND SYSTEM+1(888)541-0078sterilmedcs@its.jnj.com
10888551017862NA - BUR CEBOTOME ROUND+1(888)541-0078customerservice@sterilmed.com
10888551017862NA - BUR CEBOTOME ROUND+1(888)541-0078sterilmedcs@its.jnj.com
10888551035224NA - BUR STAINLESS STEEL ROUND MICRO 10 FLUTES+1(888)541-0078customerservice@sterilmed.com
10888551035224NA - BUR STAINLESS STEEL ROUND MICRO 10 FLUTES+1(888)541-0078sterilmedcs@its.jnj.com
10888551045292NA - MAXFRAME FULL RING, 90MM+1(888)541-0078sterilmedcs@its.jnj.com
10888551045308NA - MAXFRAME FULL RING, 120MM+1(888)541-0078sterilmedcs@its.jnj.com
10888551045315NA - 11.0MM CARBON FIBER ROD 450MM+1(888)541-0078sterilmedcs@its.jnj.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1776491535449900K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterNLH2024-10-11
1776491665353234K231473Monarch BronchoscopeQNW2023-11-28
1776491240541484K203614Monarch BronchoscopeQNW2021-03-11
1776491386429361K201806Reprocessed PentaRay Nav eco High-Density Mapping CatheterMTD2021-06-23
171021342937575K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ2019-08-15
1776491342937575K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ2019-08-15
171021424778931K190478Reprocessed ViewFlex™ Xtra ICE CatheterOWQ2019-11-14
1776491424778931K190478Reprocessed ViewFlex™ Xtra ICE CatheterOWQ2019-11-14
171021379522844K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ2019-04-15
1776491379522844K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ2019-04-15
171021897112521K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound CathetersOWQ2016-11-21
1776491897112521K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound CathetersOWQ2016-11-21
171021806254045K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT2016-11-10
1776491806254045K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT2016-11-10
171021257581101K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)NUJ2016-09-20
1776491257581101K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)NUJ2016-09-20
171021549385925K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH2016-06-23
1776491549385925K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH2016-06-23
171021414888668K152134Reprocessed Vessel SealerNUJ2016-01-15
1776491414888668K152134Reprocessed Vessel SealerNUJ2016-01-15
171021136591813K152090Reprocessed Steerable IntroducerPNE2016-03-23
1776491136591813K152090Reprocessed Steerable IntroducerPNE2016-03-23
171021433654148K150357Reprocessed Electrophysiology Diagnostic CathetersNLH2015-08-27
1776491433654148K150357Reprocessed Electrophysiology Diagnostic CathetersNLH2015-08-27
171021337054734K143562Reprocessed Cordless Ultrasonic Dissection DeviceNLQ2015-05-20
1776491337054734K143562Reprocessed Cordless Ultrasonic Dissection DeviceNLQ2015-05-20
171021568484681K143260Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/DividerNUJ2015-02-23
1776491568484681K143260Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/DividerNUJ2015-02-23
171021902412299K133414REPROCESSED CLOSURE SYSTEMNLM2014-01-22
1776491902412299K133414REPROCESSED CLOSURE SYSTEMNLM2014-01-22
171021247098776K123096REPROCESSED VESSEL SEALERNUJ2013-01-25
1776491247098776K123096REPROCESSED VESSEL SEALERNUJ2013-01-25
171021800549479K121240REPROCESSED ENDOSCOPIC TROCARSNLM2012-06-11
1776491800549479K121240REPROCESSED ENDOSCOPIC TROCARSNLM2012-06-11
171021374549402K121158REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2012-08-06
1776491374549402K121158REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2012-08-06
171021502255887K120040REPROCESSED SURGICAL ELECTRIC INSTRUMENTNUJ2012-10-05
1776491502255887K120040REPROCESSED SURGICAL ELECTRIC INSTRUMENTNUJ2012-10-05
171021819357577K111794REPROCESSED HARMONIC SCALPELNLQ2012-01-11
1776491819357577K111794REPROCESSED HARMONIC SCALPELNLQ2012-01-11
171021062203266K111002REPROCESSED ENDOSCOPIC TROCARSNLM2011-07-18
1776491062203266K111002REPROCESSED ENDOSCOPIC TROCARSNLM2011-07-18
171021760064433K110076REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETEROWQ2011-08-18
1776491760064433K110076REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETEROWQ2011-08-18
171021070291146K102560REPROCESSED PULSE OXIMETER SENSORSNLF2011-02-18
1776491070291146K102560REPROCESSED PULSE OXIMETER SENSORSNLF2011-02-18
171021979881452K101789REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2010-08-19
1776491979881452K101789REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2010-08-19
171021462389594K100707REPROCESSED PINSNDM2010-06-25
1776491462389594K100707REPROCESSED PINSNDM2010-06-25
171021902398136K092368REPROCESSED PULSE OXIMETER SENSORSNLF2009-11-03
1776491902398136K092368REPROCESSED PULSE OXIMETER SENSORSNLF2009-11-03
171021627923304K092158REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2010-01-14
1776491627923304K092158REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2010-01-14
171021707634599K083636REPROCESSED EXTERNAL FIXATION DEVICEKTT2009-03-02
1776491707634599K083636REPROCESSED EXTERNAL FIXATION DEVICEKTT2009-03-02
171021357107724K083060REPROCESSED HARMONIC SCALPELNLQ2009-01-09
1776491357107724K083060REPROCESSED HARMONIC SCALPELNLQ2009-01-09
171021430969042K081814REPROCESSED ENT SHAVERSERL2008-12-17
1776491430969042K081814REPROCESSED ENT SHAVERSERL2008-12-17
171021223137970K081586REPROCESSED EXTERNAL FIXATION DEVICEKTT2008-08-18
1776491223137970K081586REPROCESSED EXTERNAL FIXATION DEVICEKTT2008-08-18
171022010620653K081342REPROCESSED EXTERNAL FIXATION ACCESSORIESKTT2008-08-13
1776492010620653K081342REPROCESSED EXTERNAL FIXATION ACCESSORIESKTT2008-08-13
171021881825873K073613REPROCESSED SCISSOR TIPSNUJ2008-02-12
1776491881825873K073613REPROCESSED SCISSOR TIPSNUJ2008-02-12
171021137331620K052299REPROCESSED ENDOSCOPIC TROCARNLM2006-05-23
1776491137331620K052299REPROCESSED ENDOSCOPIC TROCARNLM2006-05-23
171021819376348K051957REPROCESSED EXTERNAL FIXATION DEVICEKTT2005-09-21
1776491819376348K051957REPROCESSED EXTERNAL FIXATION DEVICEKTT2005-09-21
171021713852176K051220REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2005-06-14
1776491713852176K051220REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2005-06-14
171021148991881K050343REPROCESSED HARMONIC SCALPELSNLQ2005-04-12
1776491148991881K050343REPROCESSED HARMONIC SCALPELSNLQ2005-04-12
171021256528510K050136REPROCESSED HOT BIOPSY FORCEPSNLU2005-07-20
1776491256528510K050136REPROCESSED HOT BIOPSY FORCEPSNLU2005-07-20
171021969471443K043592REPROCESSED ENDOSCOPIC TROCARNLM2005-05-23
1776491969471443K043592REPROCESSED ENDOSCOPIC TROCARNLM2005-05-23
171021150075065K043513STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERNLH2005-03-01
1776491150075065K043513STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERNLH2005-03-01
171021920413492K043453STERILEMED REPROCESSED IVUS IMAGING CATHETEROWQ2005-03-01
1776491920413492K043453STERILEMED REPROCESSED IVUS IMAGING CATHETEROWQ2005-03-01
171021770475544K042648REPROCESSED COLD BIOPSY FORCEPSNON2005-07-20
1776491770475544K042648REPROCESSED COLD BIOPSY FORCEPSNON2005-07-20
171021389728823K041127MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORSNLF2004-09-23
1776491389728823K041127MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORSNLF2004-09-23
171021890399433K033579REPROCESSED MULTIPLE CLIP APPLIERSNMJ2005-07-11
1776491890399433K033579REPROCESSED MULTIPLE CLIP APPLIERSNMJ2005-07-11
171021996665652K012679REPROCESSED RF ARTHROSCOPY PROBESGEI2001-11-08
1776491996665652K012679REPROCESSED RF ARTHROSCOPY PROBESGEI2001-11-08
171021862838063K012678REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2002-08-14
1776491862838063K012678REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2002-08-14
171021360474652K012677REPROCESSED PULSE OXIMETER SENSORSNLF2003-03-28
1776491360474652K012677REPROCESSED PULSE OXIMETER SENSORSNLF2003-03-28
171021423113944K012598REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTSNUJ2001-11-07
1776491423113944K012598REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTSNUJ2001-11-07
171021611768117K012597STERILMED REPROCESSED COMPRESSION SLEEVESJOW2002-02-11
1776491611768117K012597STERILMED REPROCESSED COMPRESSION SLEEVESJOW2002-02-11
171021221759936K012578REPROCESSED ENDOSCOPIC TROCARNLM2001-11-07
1776491221759936K012578REPROCESSED ENDOSCOPIC TROCARNLM2001-11-07
171021585198105K012571REPROCESSED HARMONICNLQ2001-11-07
1776491585198105K012571REPROCESSED HARMONICNLQ2001-11-07
171021970372285K012537REPROCESSED IMAGING CATHETERSOWQ2002-10-11
1776491970372285K012537REPROCESSED IMAGING CATHETERSOWQ2002-10-11
171021852744209K012536REPROCESSED POWERED ARTHROSCOPIC ACCESSORIESHRX2001-11-02
1776491852744209K012536REPROCESSED POWERED ARTHROSCOPIC ACCESSORIESHRX2001-11-02
171021632634625K012523REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2002-08-14
1776491632634625K012523REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSNLH2002-08-14
171021063440661
1776491063440661
171021084204416
1776491084204416
171021209232766
1776491209232766
171021372967420
1776491372967420

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NLH192024-10-11
NLQ142019-08-15
KTT142016-11-10
NUJ142016-09-20
NLM122014-01-22
OWQ102019-11-14
NLF82011-02-18
QNW22023-11-28
PNE22016-03-23
NDM22010-06-25
ERL22008-12-17
NLU22005-07-20
NON22005-07-20
NMJ22005-07-11
JOW22002-02-11
GEI22001-11-08
HRX22001-11-02
MTD12021-06-23

PMN#

65 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next