FDA 510(k) Applications Submitted by DAN KOSEDNAR

FDA 510(k) Number Submission Date Device Name Applicant
K050055 01/11/2005 GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM DATEX-OHMEDA, INC.
K200081 01/15/2020 NEUWAVE Microwave Ablation System and Accessories NeuWave Medical, Inc.
K150313 02/09/2015 Ablation Confirmation NEUWAVE MEDICAL INC.
K130399 02/19/2013 CERTUS 140 CERTUSURGGT SURGICAL TOOL NEUWAVE MEDICAL, INC.
K050597 03/09/2005 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC.
K050626 03/11/2005 GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM DATEX-OHMEDA, INC.
K050676 03/16/2005 GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) DATEX-OHMEDA, INC.
K040743 03/23/2004 MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM DATEX-OHMEDA, INC.
K060862 03/29/2006 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC.
K160936 04/04/2016 Certus 140 2.45GHz Ablation System NEUWAVE MEDICAL, INC
K050860 04/05/2005 GE DATEX-OHMEDA CENTIVA/5 VENTILATOR DATEX-OHMEDA, INC.
K171022 04/05/2017 Ablation Confirmation NeuWave Medical, Inc.
K071142 04/24/2007 GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM DATEX-OHMEDA
K161285 05/09/2016 Ablation Confirmation NEUWAVE MEDICAL, INC.
K041524 06/08/2004 GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM DATEX-OHMEDA, INC.
K061609 06/09/2006 GE DATEX-OHMEDA AISYS DATEX-OHMEDA, INC.
K041775 07/01/2004 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC.
K051895 07/13/2005 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC.
K122217 07/25/2012 CERTUS 140 2.45GHZ ABLATION SYSTEM NEUWAVE MEDICAL, INC
K032803 09/09/2003 DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM DATEX-OHMEDA
K062710 09/11/2006 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC.
K113237 11/02/2011 CERTUS 140 2.45GHZ ABLATION SYSTEM NEUWAVE MEDICAL, INC.
K163118 11/08/2016 FLEX Microwave Ablation System and Accessories NEUWAVE MEDICAL, INC.
K173756 12/11/2017 Certus 140 2.45GHz Ablation System NeuWave Medical, Inc.
K073707 12/31/2007 GE DATEX-OHMEDA AISYS DATEX-OHMEDA, INC.
K042154 08/10/2004 GE DATEX-OHMEDA AISYS CARESTATION DATEX-OHMEDA, INC.
DEN000001 01/07/2000 OHMEDA INOVENT DELIVERY SYSTEM OHMEDA MEDICAL
K990132 01/14/1999 DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC DATEX-OHMEDA, INC.
K000186 01/14/2000 DATEX-OHMEDA INOVENT DELIVERY SYSTEM DATEX-OHMEDA
K000275 01/31/2000 DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA DATEX-OHMEDA, INC.
K000706 03/02/2000 DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR DATEX-OHMEDA, INC.
K100744 03/16/2010 CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 NEUWAVE MEDICAL, INC
K002878 09/15/2000 DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER DATEX-OHMEDA, INC.
K993410 10/12/1999 DATES-OHMEDA AESTIVA SMARTVENT MRI DATEX-OHMEDA, INC.
DEN220087 12/02/2022 Edison System HistoSonics, Inc.


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