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
73–96 of 166
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
MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002
K903018
Medtronic Andover Medical, Inc.
Cardiovascular · 145d
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 Sep 27, 1990
MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE
K902429
Laerdal Mfg. Corp.
Cardiovascular · 128d
Cleared Sep 04, 1990
MODEL 610 MODIFIED
K903657
First Medical Devices Corp.
Cardiovascular · 26d
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 26, 1990
LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER
K895533
Matrix Medica, Inc.
Cardiovascular · 135d
Cleared Jan 26, 1990
MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE
K900169
Laerdal Mfg. Corp.
Cardiovascular · 14d
Cleared Jan 18, 1990
DEFIB K-PADS
K895662
Katecho, Inc.
Cardiovascular · 120d
Cleared Dec 13, 1989
DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.
K894356
Phycon
Cardiovascular · 152d
Cleared Dec 13, 1989
GEL-TAC(R)
K895009
Padeco, Inc.
Cardiovascular · 127d
Cleared Dec 12, 1989
DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.
K894355
Phycon
Cardiovascular · 151d
Cleared Dec 12, 1989
MARQUETTE 1200 DEFIBRILLATION PADS
K895651
Marquette Electronics, Inc.
Cardiovascular · 83d
Cleared Oct 27, 1989
FIRST MEDIC MODEL 610P
K895185
First Medical Devices Corp.
Cardiovascular · 77d
Cleared Oct 26, 1989
COORDINATOR
K895113
Cardiotronics, Inc.
Cardiovascular · 72d
Cleared Oct 12, 1989
P POLYMER
K893990
Pace West
Cardiovascular · 129d
Cleared Oct 12, 1989
ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES
K895032
Zmi Corp.
Cardiovascular · 65d
Cleared Sep 13, 1989
DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.
K891122
Big Valley Medical
Cardiovascular · 195d