FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K012603 |
ALLIANCE MEDICAL CORP. |
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS |
11/07/2001 |
K110189 |
ASCENT HEALTHCARE SOLUTIONS |
REPROCESSED ELECTROSURGICAL INSTRUMENT |
07/18/2011 |
K111600 |
ASCENT HEALTHCARE SOLUTIONS |
REPROCESSED HAND ACTIVATE SEALER/DIVIDER |
11/15/2011 |
K131614 |
COVIDIEN |
REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM |
08/29/2013 |
K211203 |
Green OR, LLC. |
Green OR Reprocessed Aquamantys Bipolar Sealer |
04/07/2022 |
K090661 |
Northeast Scientific, Inc. |
NES REPROCESSED VARICOSE VEIN RF CATHETER |
07/21/2010 |
K173214 |
Northeast Scientific, Inc. (NES) |
NES Reprocessed RF Stylet (RFS) |
03/27/2018 |
K173741 |
ReNovo, Inc. |
Reprocessed ArthoCare Ablation Wand |
03/05/2018 |
K172647 |
ReNovo, Inc. |
Reprocessed ArthroCare ENT Coblator |
02/21/2018 |
K173740 |
ReNovo, Inc. |
Reprocessed DePuy Mitek Ablation Wand |
03/19/2018 |
K143260 |
STERILMED, INC. |
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider |
02/23/2015 |
K161086 |
Sterilmed, Inc. |
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) |
09/20/2016 |
K012598 |
STERILMED, INC. |
REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS |
11/07/2001 |
K073613 |
STERILMED, INC. |
REPROCESSED SCISSOR TIPS |
02/12/2008 |
K120040 |
STERILMED, INC. |
REPROCESSED SURGICAL ELECTRIC INSTRUMENT |
10/05/2012 |
K123096 |
STERILMED, INC. |
REPROCESSED VESSEL SEALER |
01/25/2013 |
K152134 |
STERILMED, INC. |
Reprocessed Vessel Sealer |
01/15/2016 |
K133578 |
STRYKER SUSTAINABILITY SOLUTIONS |
REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER |
04/10/2014 |
K220411 |
Stryker Sustainability Solutions |
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) |
05/13/2022 |
K230251 |
Stryker Sustainability Solutions |
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) |
03/28/2023 |
K180451 |
Stryker Sustainability Solutions |
Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider |
04/20/2018 |
K150538 |
STRYKER SUSTAINABILITY SOLUTIONS |
Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider |
06/25/2015 |
K180499 |
Stryker Sustainability Solutions |
Reprocessed LigaSure Maryland Jaw Sealer/Divider |
04/23/2018 |
K121855 |
STRYKER SUSTAINABILITY SOLUTIONS |
RESPROCESSED SERFAS ENERGY PROBE |
08/16/2012 |
K052695 |
SURETEK MEDICAL |
SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS |
05/10/2006 |
K052692 |
SURETEK MEDICAL |
SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES |
05/10/2006 |
K052690 |
SURETEK MEDICAL |
SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS |
05/12/2006 |
K171324 |
Surgical Instrument Service and Savings Inc |
Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics |
06/23/2017 |
K160333 |
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC |
Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider |
07/20/2016 |
K172608 |
Surgical Instrument Service and Savings Inc |
Medline ReNewal Reprocessed Stryker SERF AS Energy Probes |
10/18/2017 |
K153745 |
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN |
Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider |
05/02/2016 |
K182588 |
Surgical Instrument Service and Savings Inc (dba Medline ReN |
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider |
10/31/2018 |
K152313 |
Surgical Instrument Services and Savings, Inc |
Medline ReNewal Reprocessed Endopath Endoscopic Instruments |
01/06/2016 |
K162751 |
Surgical Instrument Services and Savings, Inc |
Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider |
05/01/2017 |
K043198 |
VANGUARD MEDICAL CONCEPTS, INC. |
VANGUARD REPROCESSED ARTHROSCOPIC WANDS |
05/27/2005 |
K191073 |
Vein360, LLC |
Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter |
10/22/2019 |