FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K043358 |
ALLIANCE MEDICAL CORP. |
REPROCESSED ULTRASONIC SCALPELS |
06/06/2005 |
K093702 |
ASCENT HEALTHCARE SOLUTIONS |
REPROCESSED ULTRASONIC COAGULATING SHEARS |
03/04/2010 |
K100537 |
ASCENT HEALTHCARE SOLUTIONS |
REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE |
05/12/2010 |
K030598 |
MEDISISS |
MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS |
01/23/2004 |
K143562 |
STERILMED, INC. |
Reprocessed Cordless Ultrasonic Dissection Device |
05/20/2015 |
K012571 |
STERILMED, INC. |
REPROCESSED HARMONIC |
11/07/2001 |
K182272 |
Sterilmed, Inc. |
Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis |
04/15/2019 |
K190610 |
Sterilmed, Inc. |
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology |
08/15/2019 |
K083060 |
STERILMED, INC. |
REPROCESSED HARMONIC SCALPEL |
01/09/2009 |
K111794 |
STERILMED, INC. |
REPROCESSED HARMONIC SCALPEL |
01/11/2012 |
K050343 |
STERILMED, INC. |
REPROCESSED HARMONIC SCALPELS |
04/12/2005 |
K132566 |
STERILMED, INC. |
REPROCESSED HARMONIC SHEAR |
06/14/2014 |
K133672 |
STRYKER SUSTAINABILITY SOLUTIONS |
REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY |
05/01/2014 |
K161693 |
STRYKER SUSTAINABILITY SOLUTIONS |
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis |
02/23/2017 |
K170456 |
Stryker Sustainability Solutions |
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology |
04/05/2017 |
K173627 |
Surgical Instrument Service and Savings Inc |
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector |
07/12/2018 |
K193563 |
Surgical Instrument Service and Savings Inc (dba Medline ReN |
Medline ReNewal Reprocessed Harmonic ACE+7 Shears |
08/19/2020 |
K170955 |
Surgical Instrument Service and Savings Inc (dba Medline ReN |
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector |
07/03/2017 |
K151405 |
Surgical Instrument Services and Savings(dba Medline ReNewal |
Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology |
01/26/2016 |
K150524 |
Surgical Instrument Services and Savings, Inc |
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology |
12/16/2015 |
K124033 |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS |
01/07/2014 |
K043315 |
VANGUARD MEDICAL CONCEPTS, INC. |
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL |
03/22/2005 |
K043225 |
VANGUARD MEDICAL CONCEPTS, INC. |
VANGUARD REPROCESSED ULTRASONIC SCALPEL |
03/22/2005 |