Defibtech, LLC
Defibtech, LLC holds FDA 510(k) medical device clearances, first cleared 2002, most recent 2021, with 14 FDA device recalls on record.
Top product codes for Defibtech, LLC
FDA recalls by Defibtech, LLC
10 most recent of 14- Z-1694-2025 — Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
- Z-1692-2025 — Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(French/German dual language), DCF-E2310IT (Italian language)
- Z-1691-2025 — Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
- Z-1690-2025 — Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
- Z-1693-2025 — Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
- Z-0503-2025 — Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)
- Z-0505-2025 — Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series -Indicated for use on victims of sudden cardiac arrest (SCA.)
- Z-0504-2025 — Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)
- Z-0502-2025 — Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)
- Z-2543-2024 — RMU-2000 Automated Chest Compression Device
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Defibtech, LLC
- K211289 — RMU-2000 Automated Chest Compression System
- K141809 — RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
- K131525 — SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K113787 — DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K121853 — DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K081259 — DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K033896 — DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P
- K033144 — DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES
- K013896 — SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH
Data sourced from openFDA. This site is unofficial and independent of the FDA.