Data / Medical devices / United States / Stryker Sustainability Solutions Phoenix
Stryker Sustainability Solutions Phoenix: FDA-registered device maker in Phoenix, AZ, United States, 36 510(k) clearances
Stryker Sustainability Solutions Phoenix is registered with the FDA (registration 2090040) in Phoenix, AZ, United States. It lists 22 device types. The FDA files 36 510(k) clearances under its listings, the newest dated July 25, 2023. 3 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2090040
- FEI number
- 3002615969
- Address
- 10232 S. 51st St., Phoenix, AZ, United States, 85044
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Contract sterilizer, Reprocessor
- First device listed
- December 30, 2008
- Registered through
- 2027
- Brand names listed
- Catheter, Recording, Electrode, Reprocessed, Device, Transfer, Patient Manual, Reprocessed, G-Force, GRAVITY, Gravity, Gravity Peek Suture Anchor, HUNTER TENDON, HUNTER Tendon Implants and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2023 | K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | OWQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| May 13, 2020 | K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | NLH | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| May 8, 2019 | K182238 | Reprocessed ViewFlex Xtra ICE Catheter | OWQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| January 13, 2016 | K153415 | Reprocessed Stryker External Fixation Devices | KTT | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| January 24, 2013 | K123334 | REPROCESSED STEERABLE INTRODUCER | DYB | Substantially Equivalent | Stryker Sustainability Solutions, Inc. | accessdata.fda.gov |
| October 21, 2011 | K112292 | REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| September 26, 2011 | K112232 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| May 28, 2010 | K100254 | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| October 21, 2009 | K092425 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 | OWQ | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| April 1, 2009 | K090323 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| September 16, 2008 | K082023 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| July 9, 2008 | K081329 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| March 29, 2007 | K063076 | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER | OWQ | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| September 5, 2006 | K061759 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| August 31, 2006 | K061045 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| January 27, 2006 | K052918 | REPROCESSED EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| November 16, 2005 | K052603 | REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| November 16, 2005 | K052414 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| August 25, 2005 | K052064 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| August 25, 2005 | K052062 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| August 22, 2005 | K052065 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| June 29, 2005 | K051554 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| March 25, 2005 | K043392 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| March 23, 2005 | K043393 | REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| March 16, 2005 | K033436 | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER | OWQ | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| October 3, 2003 | K030279 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| September 24, 2003 | K030187 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Alliance Medical, Inc. | accessdata.fda.gov |
| August 8, 2003 | K030109 | ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| July 30, 2003 | K032058 | MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| May 2, 2003 | K030026 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| February 3, 2003 | K023714 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| August 13, 2002 | K012708 | ELECTROPHYSIOLOGY CATHETER | NLH | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| June 24, 2002 | K012648 | REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| June 24, 2002 | K012645 | REPROCESSED EBI EXTERNAL FIXATION DEVICES | KTW | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| June 24, 2002 | K012634 | REPROCESSED EXTERNAL FIXATION DEVICE | KTW | Substantially Equivalent | Alliance Medical, Inc. | accessdata.fda.gov |
| June 24, 2002 | K012623 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 10, 2024 | 94726 | Class II | Ongoing | Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only | Diagnostic electrophysiology (EP) catheters do not meet testing requirements. | accessdata.fda.gov |
| November 17, 2015 | 72715 | Class I | Terminated | The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adap | Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient. | accessdata.fda.gov |
| January 26, 2009 | 58937 | Not yet classified | Terminated | CAT 7205305***DYONICS***Arthroscopic Blade***3.5mm FULL RADIUS, 13cm long***Fits Power/EP-1 Motor Drives***Beige***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot num | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. | accessdata.fda.gov |
Compare with other makers
- All makers of Washer, Bolt Nut
- All makers of Catheter, Recording, Electrode, Reprocessed
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Toe, Constrained, Polymer
- All makers of Screw, Fixation, Bone
Updated July 3, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.