FDA 510(k) Applications Submitted by KATHY A. RACOSKY
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K142315 |
08/19/2014 |
MINOP Disposable Introducer 26F |
AESCULAP, INC. |
K093493 |
11/10/2009 |
AESCULAP STERILCONTAINER S |
AESCULAP, INC. |
K093649 |
11/25/2009 |
AESCULAP STERILCONTAINER S |
AESCULAP |
K203739 |
12/22/2020 |
ELAN 4 Electro Motor System |
Aesculap Inc. |
K110206 |
01/25/2011 |
AESCULAP- MEITHKE SHUNT SYSTEM |
AESCULAP, INC. |
K090299 |
02/06/2009 |
BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS |
AESCULAP IMPLANT SYSTEMS |
K140343 |
02/11/2014 |
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP |
AESCULAP, INC. |
K060437 |
02/21/2006 |
EXCIA TOTAL HIP SYSTEM WITH U-CAP |
AESCULAP, INC. |
K120559 |
02/24/2012 |
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM |
AESCULAP, INC. |
K080584 |
03/03/2008 |
METHA SHORT STEM HIP SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
K050804 |
03/30/2005 |
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM |
AESCULAP, INC. |
K100876 |
03/30/2010 |
AESCULAP MONOMAX ABSORBABLE SUTURE |
AESCULAP, INC. |
K120955 |
03/30/2012 |
COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
K050813 |
03/31/2005 |
ABC 2 SCREW |
AESCULAP, INC. |
K040864 |
04/02/2004 |
CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM |
AESCULAP |
K060918 |
04/04/2006 |
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD |
AESCULAP, INC. |
K101281 |
05/06/2010 |
VEGA KNEE SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
K061344 |
05/15/2006 |
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET |
AESCULAP, INC. |
K131500 |
05/24/2013 |
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS |
AESCULAP, INC. |
K071499 |
05/31/2007 |
COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY |
AESCULAP IMPLANT SYSTEMS, INC. |
K141687 |
06/12/2014 |
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM |
AESCULAP, INC. |
K101815 |
06/30/2010 |
ENDURO KNEE SYSTEM |
AESCULAP IMPLANT SYSTEMS |
K121976 |
07/05/2012 |
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE |
AESCULAP, INC. |
K071916 |
07/11/2007 |
METHA HIP SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
K111959 |
07/11/2011 |
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE |
AESCULAP, INC. |
K071945 |
07/13/2007 |
S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEMS |
K092143 |
07/15/2009 |
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM |
AESCULAP IMPLANT SYSTEMS, INC. |
K062085 |
07/21/2006 |
S4 SPINAL SYSTEM |
AESCULAP |
K102057 |
07/22/2010 |
TARGON FN SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
K082146 |
07/30/2008 |
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD |
AESCULAP IMPLANT SYSTEMS, INC. |
K062413 |
08/17/2006 |
AESCULAP PNEUMATIC KERRISON |
AESCULAP, INC. |
K192266 |
08/21/2019 |
M. Blue Adjustable Shunt System |
Aesculap, Inc. |
K102424 |
08/25/2010 |
PREVISION HIP SYSTEM WITH RECON RING |
AESCULAP IMPLANT SYSTEMS, LLC |
K102505 |
09/01/2010 |
HTO PLATING SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
K122734 |
09/06/2012 |
AESCULAP NOVOSYN ABSORBABLE SUTURE |
AESCULAP, INC. |
K062684 |
09/08/2006 |
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD |
AESCULAP, INC. |
K112682 |
09/15/2011 |
METHA HIP SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
K082991 |
10/07/2008 |
BIOLOX DELTA CERAMIC FEMORAL HEAD |
AESCULAP IMPLANT SYSTEMS, INC. |
K103003 |
10/12/2010 |
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM |
AESCULAP, INC. |
K043079 |
11/08/2004 |
BICONTACT HIP SYSTEM WITH U-CAP |
AESCULAP |
K073168 |
11/09/2007 |
AESCULAP PRIMELINE CONTAINER LTD. |
AESCULAP, INC. |
K083495 |
11/25/2008 |
MODIFICATION TO: METHA HIP SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
K053390 |
12/05/2005 |
COLUMBUS (CR) TOTAL KNEE SYSTEM |
AESCULAP, INC. |
K053526 |
12/19/2005 |
MICROSPEED UNI MOTOR SYSTEM |
AESCULAP, INC. |
K133890 |
12/20/2013 |
AESCULAP OPTILENE NONABSORBABLE SUTURE |
AESCULAP, INC. |
K190174 |
02/01/2019 |
Miethke Shunt System GAV 2.0 and SA 2.0 Valves |
Aesculap, Inc. |
K180321 |
02/05/2018 |
Aesculap Optilene Nonabsorbable Suture |
Aesculap, Inc. |
K170661 |
03/03/2017 |
Novosyn Quick Absorbable Suture |
Aesculap, Inc. |
K171001 |
04/04/2017 |
Monosyn Quick Synthetic Absorbable Surgical Suture |
Aesculap, Inc. |
K200950 |
04/09/2020 |
Ventricular Catheter |
Aesculap, Inc. |
K151165 |
05/01/2015 |
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture |
AESCULAP, INC. |
K161853 |
07/06/2016 |
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System |
AESCULAP INC. |
K151865 |
07/08/2015 |
PremiPatch PTFE Pledget |
AESCULAP, INC. |
K202391 |
08/21/2020 |
DIR 800 |
Aesculap, Inc. |
K172709 |
09/08/2017 |
ELAN 4 Electro Motor System Tools |
Aesculap, Inc. |
K182527 |
09/14/2018 |
ELAN 4 Tools |
Aesculap, Inc. |
K183203 |
11/19/2018 |
ELAN 4 Tools |
Aesculap, Inc. |
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