FDA 510(k) Applications Submitted by DAN KOSEDNAR, RAC
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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