FDA.reportPublic FDA data

Stryker Sustainability Solutions

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30093506903009350690Stryker Sustainability Solutions1Y2026-01-011810 W. Drake Dr. Tempe AZ US 85283

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1526021093391162K910512ACCUFLATEKCY1991-02-19
1526021391441577K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI2026-06-18
1526021244558964K250898Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)NLQ2025-08-14
1526021037440798K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)NLF2024-10-22
1526021178696986K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)NLQ2024-07-03
1526021496578910K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)NLQ2024-02-20
1526021727987288K231621Reprocessed ViewFlex Xtra ICE Catheter (D087031)OWQ2023-07-25
1526021563867513K230255Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019GEI2023-03-28
1526021914854594K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ2023-03-28
1526021689282409K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)NLF2022-12-04
1526021936308770K220481Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)GEI2022-05-25
1526021386580217K220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ2022-05-13
1526021941161412K211203Green OR Reprocessed Aquamantys Bipolar SealerNUJ2022-04-07
1526021072531902K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2DQA2022-03-08
1526021929428663K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)NLF2022-03-08
1526021898301398K202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisNLQ2021-03-16
1526021609813913K201756Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for FluentHIH2020-09-25
1526021138574692K201511Reprocessed Endoscopic Trocars and SleevesNLM2020-07-31
1526021189878369K200205Reprocessed Advisor FL Circular Mapping Catheter, Sensor EnabledNLH2020-05-13
1526021746918472K182238Reprocessed ViewFlex Xtra ICE CatheterOWQ2019-05-08
1526021433760760K180499Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ2018-04-23
1526021892650080K180451Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/DividerNUJ2018-04-20
1526021788607175K172856Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/DividerGEI2017-11-16
1526021330479776K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ2017-04-05
1526021102567714K161693Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisNLQ2017-02-23
1526021969772265K153415Reprocessed Stryker External Fixation DevicesKTT2016-01-13
1526021832861979K150538Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/DividerNUJ2015-06-25
1526021193189235K133672REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGYNLQ2014-05-01
1526021810899851K133578REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDERNUJ2014-04-10
1526021379155104K132629REPROCESSED DILATING TIP TROCARSNLM2013-12-31
1526021404423869K123334REPROCESSED STEERABLE INTRODUCERDYB2013-01-24
1526021007848299K112292REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETERNLH2011-10-21
1526021919352495K112232REPROCESSED ELECTROPHYSIOLOGY CATHETERSNLH2011-09-26
1526021459009255K100909REPROCESSED COMPRESSION SLEEVESJOW2010-07-23
1526021480607996K100254REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERNLH2010-05-28
1526021583926923K092425REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10OWQ2009-10-21
1526021298155355K090323REPROCESSED ELECTROPHYSIOLOGY CATHETERSNLH2009-04-01
1526021267125270K090308RESTEP DVY SYSTEM, MODEL RSP-101JOW2009-05-01
1526021825007210K082023REPROCESSED ELECTROPHYSIOLOGY CATHETERSNLH2008-09-16
1526021164031651K081329REPROCESSED ELECTROPHYSIOLOGY CATHETERSNLH2008-07-09
1526021626070173K081238REPROCESSED MASIMO PULSE OXIMETER SENSORSNLF2008-07-29
1526021497751862K061759REPROCESSED EXTERNAL FIXATION DEVICEKTT2006-09-05
1526021874753025K061045REPROCESSED ELECTROPHYSIOLOGY CATHETERSNLH2006-08-31
1526021049785940K060091ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVESJOW2006-02-17
1526021041660009K060049REPROCESSED COMPRESSION SLEEVESJOW2006-02-24
1526021132661746K052918REPROCESSED EXTERNAL FIXATION DEVICESKTT2006-01-27
1526022011858756K052065ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICESKTT2005-08-22
1526021029810098K052064ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICESKTT2005-08-25
1526021209108464K052062ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICESKTT2005-08-25
1526021777609181K051554ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICESKTT2005-06-29
1526021422800748K043393REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERSNLH2005-03-23
1526021906238750K042316VANGUARD REPROCESSED PULSE OXIMETER SENSORSNLF2005-01-06
1526021727564531K033436REPROCESSED DIAGNOSTIC ULTRASOUND CATHETEROWQ2005-03-16
1526021469362991K032058MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICESKTT2003-07-30
1526021616723786K030279REPROCESSED ELECTROPHYSIOLOGY CATHETERNLH2003-10-03
1526021189057655K030187REPROCESSED ELECTROPHYSIOLOGY CATHETERNLH2003-09-24
1526021174006387K030109ELECTROPHYSIOLOGY CATHETERNLH2003-08-08
1526021568647374K030026REPROCESSED ELECTROPHYSIOLOGY CATHETERNLH2003-05-02
1526021742663731K023714REPROCESSED EXTERNAL FIXATION DEVICEKTT2003-02-03
1526021566247543K012708ELECTROPHYSIOLOGY CATHETERNLH2002-08-13
1526021360648773K012645REPROCESSED EBI EXTERNAL FIXATION DEVICESKTW2002-06-24
1526022031036436K012635REPROCESSED STRYKER ARTHROSCOPIC SHAVERSHRX2001-11-07
1526021241632568K012634REPROCESSED EXTERNAL FIXATION DEVICEKTW2002-06-24
1526021318677291K012625REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTSGEI2001-10-22
1526021021502347K012623REPROCESSED EXTERNAL FIXATION DEVICEKTT2002-06-24
1526021819362512K012603REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTSNUJ2001-11-07
1526021518610266K012344VANGUARD REPROCESSED PULSE OXIMETER SENSORSNLF2002-10-04
1526021303157043
1526021516515347
1526022013574278
1526022046517753
1526022056039452
1526021185718428
1526021308396293
1526021795816219
1526021871970194
1526021956560664

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NLH142020-05-13
KTT102016-01-13
NUJ82023-03-28
NLQ72025-08-14
NLF62024-10-22
GEI52026-06-18
OWQ42023-07-25
JOW42010-07-23
NLM22020-07-31
KTW22002-06-24
DQA12022-03-08
HIH12020-09-25
DYB12013-01-24
HRX12001-11-07
KCY11991-02-19

PMN#