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
166 devices
25–48 of 166
Cleared Jul 25, 1994
PEDIATRIC DEFIB K-PADS
K935083
Katecho, Inc.
Cardiovascular · 273d
Cleared Mar 16, 1994
VITAL-COMBO(R)
K922315
Physio-Control Corp.
Cardiovascular · 667d
Cleared Feb 17, 1994
RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB
K934015
Portable Power Systems, Inc.
Cardiovascular · 184d
Cleared Feb 17, 1994
BATTERY PACK# S1024NC
K934508
Portable Power Systems, Inc.
Cardiovascular · 156d
Cleared Feb 03, 1994
BATTERY PACK #1012NC
K931266
Portable Power Systems, Inc.
Cardiovascular · 332d
Cleared Dec 16, 1993
LIFEPAK 9 DEFIBRILLATOR/MONITOR
K935674
Physio-Control Corp.
Cardiovascular · 8d
Cleared Oct 15, 1993
ZOLL PD 5300
K931787
Zoll Medical Corp
Cardiovascular · 186d
Cleared Oct 08, 1993
5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES
K931803
Zoll Medical Corp
Cardiovascular · 179d
Cleared Oct 08, 1993
ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO
K931804
Zoll Medical Corp
Cardiovascular · 179d
Cleared Oct 08, 1993
ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT
K931805
Zoll Medical Corp
Cardiovascular · 179d
Cleared Jun 25, 1993
DPD DEFIBRILLATOR
K930548
Medical Research Laboratories, Inc.
Cardiovascular · 142d
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 Oct 05, 1992
BATTERY PACK
K923864
Portable Power Systems, Inc.
Cardiovascular · 63d
Cleared Sep 18, 1992
MODEL #340 STEALTH-TRODE+LS
K923297
Cardiotronics, Inc.
Cardiovascular · 74d
Cleared Jun 11, 1992
MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)
K922172
Cardiotronics, Inc.
Cardiovascular · 34d
Cleared Jun 11, 1992
MODEL # 830 ST ADULT STIMULATION PADS (STERILE)
K922173
Cardiotronics, Inc.
Cardiovascular · 34d
Cleared Jun 11, 1992
MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE
K922227
Cardiotronics, Inc.
Cardiovascular · 30d
Cleared May 26, 1992
MODEL #125 CHILD STIMULATION PADS
K921606
Cardiotronics, Inc.
Cardiovascular · 53d
Cleared Feb 21, 1992
PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG
K912966
Physio-Control Corp.
Cardiovascular · 228d
Cleared Feb 03, 1992
SHOCK-PATCH ADULT DEFIBRILLATION PADS
K920086
Cardiotronics, Inc.
Cardiovascular · 26d
Cleared Dec 09, 1991
ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION
K914458
Medical Data Electronics
Cardiovascular · 63d
Cleared Dec 04, 1991
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
K914971
Nihon Kohden America, Inc.
Cardiovascular · 47d
Cleared Oct 16, 1991
MODEL #100 SHOCK-TRODE CHILD DEFIB PADS
K911455
Cardiotronics, Inc.
Cardiovascular · 196d