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
49–72 of 166
Cleared Sep 18, 1992
MODEL #340 STEALTH-TRODE+LS
K923297
Cardiotronics, Inc.
Cardiovascular · 74d
Cleared Jul 28, 1992
LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)
K922563
Raco Products Co.
Cardiovascular · 57d
Cleared Jul 06, 1992
LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR)
K920990
Raco Products Co.
Cardiovascular · 126d
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 16, 1991
ZOLL D-900 DEFIBRILLATOR
K913484
Zmi Corp.
Cardiovascular · 132d
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
Cleared Oct 16, 1991
MODEL #110 STEALTH-TRODE CHILD DEFIB PADS
K911456
Cardiotronics, Inc.
Cardiovascular · 196d
Cleared Oct 16, 1991
MODEL #911 STEALTH MULTI PADS
K912621
Cardiotronics, Inc.
Cardiovascular · 125d
Cleared Oct 10, 1991
MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS
K911662
Marquette Electronics, Inc.
Cardiovascular · 181d
Cleared Oct 03, 1991
MODEL #350 SHOCK-PLATE DEFIB ADAPTOR
K911402
Cardiotronics, Inc.
Cardiovascular · 188d
Cleared Sep 23, 1991
MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM)
K911604
Medphone Corp.
Cardiovascular · 166d
Cleared Aug 29, 1991
ESCORT 300 SERIES
K911665
Medical Data Electronics
Cardiovascular · 139d
Cleared Jul 30, 1991
K-FREE
K912587
Katecho, Inc.
Cardiovascular · 48d
Cleared Jul 24, 1991
DC200 DEFIBRILLATOR
K910634
Siemens Burdick, Inc.
Cardiovascular · 161d
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