FDA Product Code
FDA Product Code LDD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5300
510(k) Clearances — 166 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203231 | Switched Internal Paddles | Philips North America, LLC | 2021-01-11 | Special | PDF ↗ |
| K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020-07-24 | Traditional | PDF ↗ |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | Physio-Control, Inc. | 2019-06-03 | Traditional | PDF ↗ |
| K150349 | Rapid Hair Removal Pads | Full Power Aed | 2015-07-14 | Traditional | PDF ↗ |
| K140502 | ZOLL E SERIES ALS | ZOLL Medical Corporation | 2014-11-06 | Traditional | PDF ↗ |
| K103651 | CARDIOMED | Cardio Medical Products, Inc. | 2011-10-04 | Traditional | PDF ↗ |
| K103783 | EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC | Fiab Spa | 2011-06-16 | Traditional | PDF ↗ |
| K103334 | CARDIO MED | Cardio Medical Products, Inc. | 2011-01-18 | Traditional | PDF ↗ |
| K103159 | CARDIO MED MODEL A102, H104, O101, P103, AND Z100 | Cardio Medical Products, Inc. | 2011-01-11 | Traditional | PDF ↗ |
| K102468 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | 2010-09-30 | Special | PDF ↗ |
| K100654 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | 2010-07-29 | Traditional | PDF ↗ |
| K081442 | HEART SYNC PEDIATRIC, MODEL PED-100 | Heart Sync, LLC | 2008-09-24 | Traditional | PDF ↗ |
| K081574 | ZOLL R SERIES | ZOLL Medical Corporation | 2008-09-18 | Traditional | PDF ↗ |
| K042302 | ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE | Zoll Medical Corp | 2004-10-26 | Special | PDF ↗ |
| K032691 | ZOLL AUTOCLAVABLE INTERNAL HANDLES | Zoll Medical Corp | 2003-11-13 | Traditional | PDF ↗ |
| K030417 | DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES | Philips Medical Systems | 2003-05-09 | Traditional | PDF ↗ |
| K011461 | ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR | Access Cardiosystems, Inc. | 2002-05-28 | Traditional | PDF ↗ |
| K012274 | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER | Medtronic Physio-Control Corp. | 2002-02-05 | Traditional | PDF ↗ |
| K993205 | BOOKER BOX, MODEL PAD 5010 | Tz Medical, Inc. | 2000-07-20 | Traditional | PDF ↗ |
| K982896 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 | Alexander Mfg. Co. | 1998-10-21 | Traditional | PDF ↗ |
| K971436 | NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES | Nihon Kohden America, Inc. | 1997-10-21 | Traditional | PDF ↗ |
| K971355 | NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES | Nihon Kohden America, Inc. | 1997-07-15 | Traditional | PDF ↗ |
| K971194 | NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES | Nihon Kohden America, Inc. | 1997-07-09 | Traditional | PDF ↗ |
| K970481 | V2 | Survivalink Corp. | 1997-07-01 | Traditional | PDF ↗ |
| K963781 | ZOLL AUTOCLAVABLE INTERNAL HANDLES | Zoll Medical Corp | 1997-05-20 | Traditional | PDF ↗ |
| K964469 | 700-F SERIES STIMULATION ELECTRODES | Cardiotronics Systems, Inc. | 1996-12-11 | Traditional | PDF ↗ |
| K962551 | CARDIOSERV S | Marquette Electronics, Inc. | 1996-11-19 | Traditional | PDF ↗ |
| K951110 | CARDIO SERV | Hellige GmbH | 1995-09-15 | Traditional | PDF ↗ |
| K952085 | DPD DEFIBRILLATOR | Medical Research Laboratories, Inc. | 1995-06-05 | Traditional | PDF ↗ |
| K940842 | UNIPOWER RECHARGEABLE BATTERY PACK | Unipower Corp. | 1994-09-07 | Traditional | PDF ↗ |
| K941995 | NCE REPLACEMENT BATTERIES | National Custom Ent., Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K935083 | PEDIATRIC DEFIB K-PADS | Katecho, Inc. | 1994-07-25 | Traditional | PDF ↗ |
| K935111 | UNIPOWERR RECHARGEABLE BATTERY PACK | Unipower Corp. | 1994-03-28 | Traditional | PDF ↗ |
| K922315 | VITAL-COMBO(R) | Physio-Control Corp. | 1994-03-16 | Traditional | PDF ↗ |
| K934015 | RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB | Portable Power Systems, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K934508 | BATTERY PACK# S1024NC | Portable Power Systems, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K931266 | BATTERY PACK #1012NC | Portable Power Systems, Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K935674 | LIFEPAK 9 DEFIBRILLATOR/MONITOR | Physio-Control Corp. | 1993-12-16 | Traditional | PDF ↗ |
| K931787 | ZOLL PD 5300 | Zoll Medical Corp | 1993-10-15 | Traditional | PDF ↗ |
| K931804 | ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO | Zoll Medical Corp | 1993-10-08 | Traditional | PDF ↗ |
| K931805 | ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT | Zoll Medical Corp | 1993-10-08 | Traditional | PDF ↗ |
| K931803 | 5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES | Zoll Medical Corp | 1993-10-08 | Traditional | PDF ↗ |
| K921666 | CARDIAC THERAPHY SYSTEM SCP 900 | Ppg Hellige B.V. | 1993-09-23 | Traditional | PDF ↗ |
| K930548 | DPD DEFIBRILLATOR | Medical Research Laboratories, Inc. | 1993-06-25 | Traditional | PDF ↗ |
| K931053 | LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER | Physio-Control Corp. | 1993-05-18 | Traditional | PDF ↗ |
| K921765 | PRIMEDIC DEFIBRILLATORS-N/B | Metronic Electronic GmbH | 1993-03-03 | Traditional | PDF ↗ |
| K921487 | MARQUETTE SERIES 360 DEFIBRILLATOR | Marquette Electronics, Inc. | 1992-12-29 | Traditional | PDF ↗ |
| K923864 | BATTERY PACK | Portable Power Systems, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K923297 | MODEL #340 STEALTH-TRODE+LS | Cardiotronics, Inc. | 1992-09-18 | Traditional | PDF ↗ |
| K922563 | LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) | Raco Products Co. | 1992-07-28 | Traditional | PDF ↗ |
| K920990 | LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR) | Raco Products Co. | 1992-07-06 | Traditional | PDF ↗ |
| K922173 | MODEL # 830 ST ADULT STIMULATION PADS (STERILE) | Cardiotronics, Inc. | 1992-06-11 | Traditional | PDF ↗ |
| K922227 | MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE | Cardiotronics, Inc. | 1992-06-11 | Traditional | PDF ↗ |
| K922172 | MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) | Cardiotronics, Inc. | 1992-06-11 | Traditional | PDF ↗ |
| K921606 | MODEL #125 CHILD STIMULATION PADS | Cardiotronics, Inc. | 1992-05-26 | Traditional | PDF ↗ |
| K912966 | PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG | Physio-Control Corp. | 1992-02-21 | Traditional | PDF ↗ |
| K920086 | SHOCK-PATCH ADULT DEFIBRILLATION PADS | Cardiotronics, Inc. | 1992-02-03 | Traditional | PDF ↗ |
| K913484 | ZOLL D-900 DEFIBRILLATOR | Zmi Corp. | 1991-12-16 | Traditional | PDF ↗ |
| K914458 | ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION | Medical Data Electronics | 1991-12-09 | Traditional | PDF ↗ |
| K914971 | TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION | Nihon Kohden America, Inc. | 1991-12-04 | Traditional | PDF ↗ |
| K911455 | MODEL #100 SHOCK-TRODE CHILD DEFIB PADS | Cardiotronics, Inc. | 1991-10-16 | Traditional | PDF ↗ |
| K911456 | MODEL #110 STEALTH-TRODE CHILD DEFIB PADS | Cardiotronics, Inc. | 1991-10-16 | Traditional | PDF ↗ |
| K912621 | MODEL #911 STEALTH MULTI PADS | Cardiotronics, Inc. | 1991-10-16 | Traditional | PDF ↗ |
| K911662 | MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS | Marquette Electronics, Inc. | 1991-10-10 | Traditional | PDF ↗ |
| K911402 | MODEL #350 SHOCK-PLATE DEFIB ADAPTOR | Cardiotronics, Inc. | 1991-10-03 | Traditional | PDF ↗ |
| K911604 | MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM) | Medphone Corp. | 1991-09-23 | Traditional | PDF ↗ |
| K911665 | ESCORT 300 SERIES | Medical Data Electronics | 1991-08-29 | Traditional | PDF ↗ |
| K912587 | K-FREE | Katecho, Inc. | 1991-07-30 | Traditional | PDF ↗ |
| K910634 | DC200 DEFIBRILLATOR | Siemens Burdick, Inc. | 1991-07-24 | Traditional | PDF ↗ |
| K910144 | 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON | Physio-Control Corp. | 1991-07-17 | Traditional | PDF ↗ |
| K910754 | MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION | Hewlett-Packard Co. | 1991-05-08 | Traditional | PDF ↗ |
| K905065 | DEFIBRILLATOR LEAD ADAPTER | Spacelabs, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K902288 | MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR | Physio-Control Corp. | 1991-02-25 | Traditional | PDF ↗ |
| K904466 | MODEL #250 DEFIB CABLE | Cardiotronics, Inc. | 1991-01-30 | Traditional | PDF ↗ |
| K902782 | SERIES 1500 RESPONDER | Marquette Electronics, Inc. | 1991-01-18 | Traditional | PDF ↗ |
| K896903 | FIRST MEDIC MODEL 510 | Spacelabs, Inc. | 1990-12-27 | Traditional | PDF ↗ |
| K905510 | LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED | Physio-Control Corp. | 1990-12-20 | Traditional | PDF ↗ |
| K903018 | MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002 | Medtronic Andover Medical, Inc. | 1990-12-03 | Traditional | PDF ↗ |
| K904462 | MODEL #210 STEALTH DEFIB PADS | Cardiotronics, Inc. | 1990-12-03 | Traditional | PDF ↗ |
| K902478 | LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR | Physio-Control Corp. | 1990-10-31 | Traditional | PDF ↗ |
| K902429 | MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE | Laerdal Mfg. Corp. | 1990-09-27 | Traditional | PDF ↗ |
| K903657 | MODEL 610 MODIFIED | First Medical Devices Corp. | 1990-09-04 | Traditional | PDF ↗ |
| K902590 | THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT | Marquette Electronics, Inc. | 1990-07-18 | Traditional | PDF ↗ |
| K895379 | LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) | Physio-Control Corp. | 1990-02-26 | Traditional | PDF ↗ |
| K895533 | LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER | Matrix Medica, Inc. | 1990-01-26 | Traditional | PDF ↗ |
| K900169 | MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE | Laerdal Mfg. Corp. | 1990-01-26 | Traditional | PDF ↗ |
| K895662 | DEFIB K-PADS | Katecho, Inc. | 1990-01-18 | Traditional | PDF ↗ |
| K895009 | GEL-TAC(R) | Padeco, Inc. | 1989-12-13 | Traditional | PDF ↗ |
| K894356 | DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB. | Phycon | 1989-12-13 | Traditional | PDF ↗ |
| K894355 | DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT. | Phycon | 1989-12-12 | Traditional | PDF ↗ |
| K895651 | MARQUETTE 1200 DEFIBRILLATION PADS | Marquette Electronics, Inc. | 1989-12-12 | Traditional | PDF ↗ |
| K895185 | FIRST MEDIC MODEL 610P | First Medical Devices Corp. | 1989-10-27 | Traditional | PDF ↗ |
| K895113 | COORDINATOR | Cardiotronics, Inc. | 1989-10-26 | Traditional | PDF ↗ |
| K893990 | P POLYMER | Pace West | 1989-10-12 | Traditional | PDF ↗ |
| K895032 | ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES | Zmi Corp. | 1989-10-12 | Traditional | PDF ↗ |
| K891122 | DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE. | Big Valley Medical | 1989-09-13 | Traditional | PDF ↗ |
| K893403 | MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE | Hewlett-Packard Co. | 1989-08-03 | Traditional | PDF ↗ |
| K890079 | LIFEPAK 10 DEFIBRILLATOR/MONITOR | Physio-Control Corp. | 1989-02-23 | Traditional | PDF ↗ |
| K885186 | HEARTSTART 2000 DEFIBRILLATION ELECTRODE | Laerdal Mfg. Corp. | 1989-02-23 | Traditional | PDF ↗ |
| K883617 | LIFEPAK 50 MONITOR/DEFIBRILLATOR | Physio-Control Corp. | 1988-12-28 | Traditional | PDF ↗ |
Product code LDD · Class II · Cardiovascular. Data: openFDA.