FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K011461 |
ACCESS CARDIOSYSTEMS, INC. |
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR |
05/28/2002 |
K982896 |
ALEXANDER MFG. CO. |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 |
10/21/1998 |
K103334 |
CARDIO MEDICAL PRODUCTS, INC. |
CARDIO MED |
01/18/2011 |
K103159 |
CARDIO MEDICAL PRODUCTS, INC. |
CARDIO MED MODEL A102, H104, O101, P103, AND Z100 |
01/11/2011 |
K103651 |
CARDIO MEDICAL PRODUCTS, INC. |
CARDIOMED |
10/04/2011 |
K964469 |
CARDIOTRONICS SYSTEMS, INC. |
700-F SERIES STIMULATION ELECTRODES |
12/11/1996 |
K103783 |
FIAB S.P.A. |
EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC |
06/16/2011 |
K150349 |
FULL POWER AED |
Rapid Hair Removal Pads |
07/14/2015 |
K081442 |
HEART SYNC LLC |
HEART SYNC PEDIATRIC, MODEL PED-100 |
09/24/2008 |
K962551 |
MARQUETTE ELECTRONICS, INC. |
CARDIOSERV S |
11/19/1996 |
K012274 |
MEDTRONIC PHYSIO-CONTROL CORP. |
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER |
02/05/2002 |
K971194 |
NIHON KOHDEN AMERICA, INC. |
NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES |
07/09/1997 |
K971436 |
NIHON KOHDEN AMERICA, INC. |
NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES |
10/21/1997 |
K971355 |
NIHON KOHDEN AMERICA, INC. |
NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES |
07/15/1997 |
K030417 |
PHILIPS MEDICAL SYSTEMS |
DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES |
05/09/2003 |
K203231 |
Philips North America LLC |
Switched Internal Paddles |
01/11/2021 |
K182503 |
Physio-Control, Inc. |
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors |
06/03/2019 |
K200849 |
Remote Diagnostic Technologies, Ltd, a Philips Company |
Tempus LS - Manual |
07/24/2020 |
K970481 |
SURVIVALINK CORP. |
V2 |
07/01/1997 |
K993205 |
TZ MEDICAL, INC. |
BOOKER BOX, MODEL PAD 5010 |
07/20/2000 |
K032691 |
ZOLL MEDICAL CORP. |
ZOLL AUTOCLAVABLE INTERNAL HANDLES |
11/13/2003 |
K963781 |
ZOLL MEDICAL CORP. |
ZOLL AUTOCLAVABLE INTERNAL HANDLES |
05/20/1997 |
K042302 |
ZOLL MEDICAL CORP. |
ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE |
10/26/2004 |
K140502 |
ZOLL MEDICAL CORPORATION |
ZOLL E SERIES ALS |
11/06/2014 |
K081574 |
ZOLL MEDICAL CORPORATION |
ZOLL R SERIES |
09/18/2008 |
K100654 |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
ZOLL PROPAQ MD |
07/29/2010 |
K102468 |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
ZOLL PROPAQ MD |
09/30/2010 |