LDD · Class II · 21 CFR 870.5300

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

Leading manufacturers include Physio-Control Corp., Nihon Kohden America, Inc. and Marquette Electronics, 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 May 09, 2003
DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES
K030417
Philips Medical Systems
Cardiovascular · 88d
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 Nov 19, 1996
CARDIOSERV S
K962551
Marquette Electronics, Inc.
Cardiovascular · 144d
Cleared Mar 16, 1994
VITAL-COMBO(R)
K922315
Physio-Control Corp.
Cardiovascular · 667d
Cleared Dec 16, 1993
LIFEPAK 9 DEFIBRILLATOR/MONITOR
K935674
Physio-Control Corp.
Cardiovascular · 8d
Cleared May 18, 1993
LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER
K931053
Physio-Control Corp.
Cardiovascular · 71d
Cleared Dec 29, 1992
MARQUETTE SERIES 360 DEFIBRILLATOR
K921487
Marquette Electronics, Inc.
Cardiovascular · 274d
Cleared Feb 21, 1992
PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG
K912966
Physio-Control Corp.
Cardiovascular · 228d
Cleared Dec 04, 1991
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
K914971
Nihon Kohden America, Inc.
Cardiovascular · 47d
Cleared Oct 10, 1991
MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS
K911662
Marquette Electronics, Inc.
Cardiovascular · 181d
Cleared Jul 17, 1991
12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON
K910144
Physio-Control Corp.
Cardiovascular · 184d
Cleared May 08, 1991
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
K910754
Hewlett-Packard Co.
Cardiovascular · 86d
Cleared Apr 12, 1991
DEFIBRILLATOR LEAD ADAPTER
K905065
Spacelabs, Inc.
Cardiovascular · 156d
Cleared Feb 25, 1991
MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR
K902288
Physio-Control Corp.
Cardiovascular · 279d
Cleared Jan 18, 1991
SERIES 1500 RESPONDER
K902782
Marquette Electronics, Inc.
Cardiovascular · 206d
Cleared Dec 27, 1990
FIRST MEDIC MODEL 510
K896903
Spacelabs, Inc.
Cardiovascular · 384d
Cleared Dec 20, 1990
LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED
K905510
Physio-Control Corp.
Cardiovascular · 13d
Cleared Oct 31, 1990
LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR
K902478
Physio-Control Corp.
Cardiovascular · 149d

About Product Code LDD - Regulatory Context