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
97–120 of 166
Cleared Aug 03, 1989
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403
Hewlett-Packard Co.
Cardiovascular · 94d
Cleared Feb 23, 1989
HEARTSTART 2000 DEFIBRILLATION ELECTRODE
K885186
Laerdal Mfg. Corp.
Cardiovascular · 71d
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
Cleared Oct 05, 1988
POLY-TAC
K882235
Cardiovascular Group, Inc.
Cardiovascular · 131d
Cleared Aug 02, 1988
CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES
K880575
Nihon Kohden America, Inc.
Cardiovascular · 174d
Cleared Aug 02, 1988
MODEL #825 ADULT STIM. PADS POLYMER TYPE
K882337
Cardiotronics, Inc.
Cardiovascular · 57d
Cleared Jul 27, 1988
LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR
K881153
Physio-Control Corp.
Cardiovascular · 132d
Cleared Jan 28, 1988
450SLL DEFIBRILLATOR
K874204
Medical Research Laboratories, Inc.
Cardiovascular · 105d
Cleared Dec 15, 1987
STRATUM D
K874697
Alternative Design Systems, Inc.
Cardiovascular · 26d
Cleared Nov 27, 1987
TELEPHONE DEFIBRILLATOR SYSTEM
K864257
Medphone Corp.
Cardiovascular · 394d
Cleared Nov 23, 1987
360D DC DEFIBRILLATOR
K874091
Medac, Inc.
Cardiovascular · 47d
Cleared Oct 09, 1987
DP-700 NIKMAN DEFIB-PADS
K872793
Nikomed U.S.A., Inc.
Cardiovascular · 87d
Cleared May 20, 1987
FAST-PATCH(TM)
K871224
Physio-Control Corp.
Cardiovascular · 54d
Cleared May 12, 1987
HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE
K871135
First Medical Devices Corp.
Cardiovascular · 53d
Cleared May 12, 1987
HEARTSTART 2000, MANUAL DEFIBRILLATOR
K871136
First Medical Devices Corp.
Cardiovascular · 53d
Cleared Nov 12, 1986
K-STIK DEFIBRILLATION PADS
K863899
Katecho, Inc.
Cardiovascular · 36d
Cleared Oct 31, 1986
CARDIOLIFE TEC 7100
K863404
Nihon Kohden America, Inc.
Cardiovascular · 58d
Cleared Oct 31, 1986
CARDIOLIFE TEC 7200
K863405
Nihon Kohden America, Inc.
Cardiovascular · 58d
Cleared Sep 05, 1986
MODEL 617D
K863303
Quinton, Inc.
Cardiovascular · 11d
Cleared Mar 31, 1986
DEFIB-PADS
K855082
Conmedcorp
Cardiovascular · 102d
Cleared Jan 13, 1986
DEFIGARD 2000
K854175
Odam
Cardiovascular · 90d
Cleared Dec 04, 1985
KONTRON DEFIBRILLATOR 7501
K854307
Kontron Instruments, Inc.
Cardiovascular · 40d
Cleared Nov 05, 1985
CR 280/45, CR281/4 DEFIBRILLATOR
K852905
Cardiac Recorders, Ltd.
Cardiovascular · 119d