LDD · Class II · 21 CFR 870.5300

FDA Product Code LDD: Dc-defibrillator, Low-energy, (including Paddles)

Leading manufacturers include Physio-Control Corp., Cardiotronics, Inc. and Nihon Kohden America, Inc..

166
Total
166
Cleared
120d
Avg days
1978
Since

FDA 510(k) Cleared Dc-defibrillator, Low-energy, (including Paddles) Devices (Product Code LDD)

166 devices
1–24 of 166
Cleared Jan 11, 2021
Switched Internal Paddles
K203231
Philips North America, LLC
Cardiovascular · 70d
Cleared Jul 24, 2020
Tempus LS - Manual
K200849
Remote Diagnostic Technologies, Ltd. A Philips Company
Cardiovascular · 115d
Cleared Jun 03, 2019
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
K182503
Physio-Control, Inc.
Cardiovascular · 264d
Cleared Jul 14, 2015
Rapid Hair Removal Pads
K150349
Full Power Aed
Cardiovascular · 153d
Cleared Nov 06, 2014
ZOLL E SERIES ALS
K140502
ZOLL Medical Corporation
Cardiovascular · 252d
Cleared Oct 04, 2011
CARDIOMED
K103651
Cardio Medical Products, Inc.
Cardiovascular · 294d
Cleared Jun 16, 2011
EURO DEFI PADS ADULT
K103783
Fiab Spa
Cardiovascular · 171d
Cleared Jan 18, 2011
CARDIO MED
K103334
Cardio Medical Products, Inc.
Cardiovascular · 64d
Cleared Jan 11, 2011
CARDIO MED MODEL A102, H104, O101, P103, AND Z100
K103159
Cardio Medical Products, Inc.
Cardiovascular · 77d
Cleared Sep 30, 2010
ZOLL PROPAQ MD
K102468
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 31d
Cleared Jul 29, 2010
ZOLL PROPAQ MD
K100654
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 143d
Cleared Sep 24, 2008
HEART SYNC PEDIATRIC, MODEL PED-100
K081442
Heart Sync, LLC
Cardiovascular · 125d
Cleared Sep 18, 2008
ZOLL R SERIES
K081574
ZOLL Medical Corporation
Cardiovascular · 105d
Cleared Oct 26, 2004
ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
K042302
Zoll Medical Corp
Cardiovascular · 62d
Cleared Nov 13, 2003
ZOLL AUTOCLAVABLE INTERNAL HANDLES
K032691
Zoll Medical Corp
Cardiovascular · 72d
Cleared May 09, 2003
DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES
K030417
Philips Medical Systems
Cardiovascular · 88d
Cleared May 28, 2002
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR
K011461
Access Cardiosystems, Inc.
Cardiovascular · 379d
Cleared Feb 05, 2002
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
K012274
Medtronic Physio-Control Corp.
Cardiovascular · 201d
Cleared Jul 20, 2000
BOOKER BOX, MODEL PAD 5010
K993205
Tz Medical, Inc.
Cardiovascular · 300d
Cleared Oct 21, 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
K982896
Alexander Mfg. Co.
Cardiovascular · 65d
Cleared Oct 21, 1997
NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
K971436
Nihon Kohden America, Inc.
Cardiovascular · 186d
Cleared Jul 15, 1997
NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
K971355
Nihon Kohden America, Inc.
Cardiovascular · 95d
Cleared Jul 09, 1997
NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES
K971194
Nihon Kohden America, Inc.
Cardiovascular · 99d
Cleared Jul 01, 1997
V2
K970481
Survivalink Corp.
Cardiovascular · 141d

About Product Code LDD - Regulatory Context