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 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 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 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 30, 1991
MODEL #250 DEFIB CABLE
K904466
Cardiotronics, Inc.
Cardiovascular · 121d
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 Dec 03, 1990
MODEL #210 STEALTH DEFIB PADS
K904462
Cardiotronics, Inc.
Cardiovascular · 63d
Cleared Oct 31, 1990
LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR
K902478
Physio-Control Corp.
Cardiovascular · 149d
Cleared Jul 18, 1990
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
K902590
Marquette Electronics, Inc.
Cardiovascular · 36d
Cleared Feb 26, 1990
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
K895379
Physio-Control Corp.
Cardiovascular · 180d
Cleared Jan 18, 1990
DEFIB K-PADS
K895662
Katecho, Inc.
Cardiovascular · 120d
Cleared Dec 12, 1989
MARQUETTE 1200 DEFIBRILLATION PADS
K895651
Marquette Electronics, Inc.
Cardiovascular · 83d
Cleared Oct 26, 1989
COORDINATOR
K895113
Cardiotronics, Inc.
Cardiovascular · 72d
Cleared Aug 03, 1989
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403
Hewlett-Packard Co.
Cardiovascular · 94d
Cleared Feb 23, 1989
LIFEPAK 10 DEFIBRILLATOR/MONITOR
K890079
Physio-Control Corp.
Cardiovascular · 50d
Cleared Dec 28, 1988
LIFEPAK 50 MONITOR/DEFIBRILLATOR
K883617
Physio-Control Corp.
Cardiovascular · 126d