Stryker Sustainability Solutions
Lakeland, FL, US
Stryker Sustainability Solutions appears in FDA device records in Lakeland, FL. FDA records list 88 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 108 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to Stryker Sustainability Solutions carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Ascent Healthcare Solutions510(k), recall
- Stryker Sustainability Solutions Lakelandregistration
- Stryker Sustainability Solutions Phoenixregistration
- Vanguard Medical Concepts, Inc.510(k), recall
510(k) clearance history
Showing 50 of 88FDA records hold 88 510(k) clearances for Stryker Sustainability Solutions between 1991 and 2026. The busiest year on record is 2005, with 14. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 2001 | 7 |
| 2002 | 6 |
| 2003 | 4 |
| 2004 | 1 |
| 2005 | 14 |
| 2006 | 2 |
| 2007 | 7 |
| 2008 | 3 |
| 2009 | 2 |
| 2010 | 5 |
| 2011 | 4 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 5 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | GEI | Substantially Equivalent | |
| K250898 | Reprocessed 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) | NLQ | Substantially Equivalent | |
| K241758 | Reprocessed 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) | NLF | Substantially Equivalent | |
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) | NLQ | Substantially Equivalent | |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) | NLQ | Substantially Equivalent | |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | OWQ | Substantially Equivalent | |
| K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 | GEI | Substantially Equivalent | |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | NUJ | Substantially Equivalent | |
| K222019 | Reprocessed 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) | NLF | Substantially Equivalent | |
| K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) | GEI | Substantially Equivalent | |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | NUJ | Substantially Equivalent | |
| K211140 | Reprocessed 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 O2 | DQA | Substantially Equivalent | |
| K211138 | Reprocessed 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) | NLF | Substantially Equivalent | |
| K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis | NLQ | Substantially Equivalent | |
| K201756 | Reprocessed 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 Fluent | HIH | Substantially Equivalent | |
| K201511 | Reprocessed Endoscopic Trocars and Sleeves | NLM | Substantially Equivalent | |
| K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | NLH | Substantially Equivalent | |
| K182238 | Reprocessed ViewFlex Xtra ICE Catheter | OWQ | Substantially Equivalent | |
| K181056 | Reprocessed CS Diagnostic Electrophysiology Catheter | NLH | Substantially Equivalent | |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | NUJ | Substantially Equivalent | |
| K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider | NUJ | Substantially Equivalent | |
| K172856 | Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider | GEI | Substantially Equivalent | |
| K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | NLQ | Substantially Equivalent | |
| K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis | NLQ | Substantially Equivalent | |
| K153415 | Reprocessed Stryker External Fixation Devices | KTT | Substantially Equivalent | |
| K150538 | Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider | NUJ | Substantially Equivalent | |
| K133672 | REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY | NLQ | Substantially Equivalent | |
| K133578 | REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER | NUJ | Substantially Equivalent | |
| K132629 | REPROCESSED DILATING TIP TROCARS | NLM | Substantially Equivalent | |
| K123334 | REPROCESSED STEERABLE INTRODUCER | DYB | Substantially Equivalent | |
| K121913 | REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER | OWQ | Substantially Equivalent | |
| K121855 | RESPROCESSED SERFAS ENERGY PROBE | NUJ | Substantially Equivalent | |
| K111600 | REPROCESSED HAND ACTIVATE SEALER/DIVIDER | NUJ | Substantially Equivalent | |
| K112292 | REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | |
| K112232 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | |
| K110189 | REPROCESSED ELECTROSURGICAL INSTRUMENT | NUJ | Substantially Equivalent | |
| K100909 | REPROCESSED COMPRESSION SLEEVES | JOW | Substantially Equivalent | |
| K100254 | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | |
| K100537 | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE | NLQ | Substantially Equivalent | |
| K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT | NLM | Substantially Equivalent | |
| K093702 | REPROCESSED ULTRASONIC COAGULATING SHEARS | NLQ | Substantially Equivalent | |
| K092425 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 | OWQ | Substantially Equivalent | |
| K090323 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | |
| K082023 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | |
| K081238 | REPROCESSED MASIMO PULSE OXIMETER SENSORS | NLF | Substantially Equivalent | |
| K081329 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | |
| K063788 | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS | NLM | Substantially Equivalent | |
| K070059 | REPROCESSED TROCARS | NLM | Substantially Equivalent | |
| K070036 | REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES | NQG | Substantially Equivalent | |
| K070034 | REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES | NQG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009350690 | 3009350690 | Stryker Sustainability Solutions | 1810 W. Drake Dr., Tempe, AZ 85283 US | 2026 | and 15 more, listed in full below |
| 1056128 | 1000132435 | Stryker Sustainability Solutions Lakeland | 5307 Great Oak Drive, LAKELAND, FL 33815 US | 2026 | |
| 2090040 | 3002615969 | Stryker Sustainability Solutions Phoenix | 10232 S. 51st St., Phoenix, AZ 85044 US | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component
- HRXArthroscope
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- NLHCatheter, Recording, Electrode, Reprocessed
- OBJCatheter, Ultrasound, Intravascular
- NMFClamp, Vascular, Reprocessed
- FZPClip, Implantable
- JECComponent, Traction, Invasive
- FRZDevice, Patient Transfer, Powered
- FMRDevice, Transfer, Patient, Manual
- KKXDrape, Surgical, Antimicrobial
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- NLUForceps, Biopsy, Electric, Reprocessed
- NONForceps, Biopsy, Non-Electric, Reprocessed
- HIHHysteroscope (And Accessories)
- LFLInstrument, Ultrasonic Surgical
- DYBIntroducer, Catheter
- GCJLaparoscope, General & Plastic Surgery
- NLMLaparoscope, General & Plastic Surgery, Reprocessed
- NWVLaparoscopic Accessories, Gynecologic
- KMIMonitor, Bed Patient
- NKXNeedle, Phacoemulsification, Reprocessed
- DQAOximeter
- NLFOximeter, Reprocessed
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- FWPProsthesis, Chin, Internal
- KWFProsthesis, Finger, Polymer
- HXAProsthesis, Tendon, Passive
- KWHProsthesis, Toe, Constrained, Polymer
- KYIProsthesis, Wrist, Carpal Trapezium
- OWQReprocessed Intravascular Ultrasound Catheter
- LRWScissors, General, Surgical
- HWCScrew, Fixation, Bone
- NLQSingle-Use Reprocessed Ultrasonic Surgical Instruments
- JOWSleeve, Limb, Compressible
- HXRSpatula, Orthopedic
- NQGStabilizer, Heart, Non-Compression, Reprocessed
- GDWStaple, Implantable
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- MAVSyringe, Balloon Inflation
- KCYTourniquet, Pneumatic
- HTNWasher, Bolt Nut
Recall records
Showing 25 of 108| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2199-2026 | Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2198-2026 | Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2197-2026 | Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2196-2026 | Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2195-2026 | Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2194-2026 | Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2193-2026 | Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2192-2026 | Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2191-2026 | Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2190-2026 | Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2189-2026 | Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2188-2026 | Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2187-2026 | Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2186-2026 | Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2185-2026 | CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2184-2026 | CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2183-2026 | BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2182-2026 | BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2181-2026 | BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2180-2026 | BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2179-2026 | BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2178-2026 | BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2177-2026 | BARD Dynamic Tip Steerable, Product Number 6DYNTP001; | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2176-2026 | BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified | |
| Z-2175-2026 | BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Incomplete seals on sterile product | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain