FDA 510(k) Applications Submitted by Stephanie Boyle Mays
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K250545 |
02/25/2025 |
Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) |
Surgical Instrument Service and Savings Inc. |
| K240972 |
04/09/2024 |
Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) |
Surgical Instrument Service and Savings Inc. |
| K191018 |
04/17/2019 |
Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors |
Surgical Instrument Service and Savings Inc |
| K241156 |
04/26/2024 |
Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, |
Surgical Instrument Service and Savings Inc. |
| K241224 |
05/02/2024 |
Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD7 |
Surgical Instrument Service and Savings Inc.(dba Medline ReN |
| K181738 |
07/02/2018 |
Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors |
Surgical Instrument Service and Savings Inc (dba Medline |
| K242225 |
07/29/2024 |
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter |
Surgical Instrument Service and Savings Inc. |
| K232511 |
08/18/2023 |
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) |
Surgical Instrument Service and Savings Inc. |
| K182588 |
09/20/2018 |
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider |
Surgical Instrument Service and Savings Inc (dba Medline ReN |
| K243101 |
09/30/2024 |
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) |
Surgical Instrument Service and Savings Inc. |
| K234064 |
12/22/2023 |
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) |
Surgical Instrument Service and Savings Inc. |
| K180580 |
03/05/2018 |
Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices |
Surgical Instrument Service and Savings Inc |
| K221067 |
04/12/2022 |
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter |
Surgical Instrument Service and Savings Inc. |
| K201699 |
06/22/2020 |
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor |
Surgical Instrument and Savings Inc (dba Medline ReNewal) |
| K171911 |
06/26/2017 |
Medline ReNewal Reprocessed Synthes External Fixation Systems |
Surgical Instrument Service and Savings Inc |
| K232130 |
07/17/2023 |
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter |
Surgical Instrument Services and Savings, Inc |
| K172608 |
08/31/2017 |
Medline ReNewal Reprocessed Stryker SERF AS Energy Probes |
Surgical Instrument Service and Savings Inc |
| K182828 |
10/05/2018 |
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer |
Surgical Instrument Service and Savings Inc |
| K173627 |
11/24/2017 |
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector |
Surgical Instrument Service and Savings Inc |
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