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Device Explorer · FDA GUDID · GMDN 47270

Cardiac resynchronization therapy implantable defibrillator

An implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (tri

US‑registered devices98in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

St. Jude Medical, Inc.3435%
Biotronik Se & Co. Kg2323%
Boston Scientific Corporation2121%
Medtronic, Inc.1515%
Microport Crm Srl55%

Top labelers

CompanyDevicesShare
St. Jude Medical, Inc.3435%
Biotronik Se & Co. Kg2323%
Boston Scientific Corporation2121%
Medtronic, Inc.1515%
Microport Crm Srl55%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Entrant™Gallant™Neutrino™QUADRA ASSURA MP™Quadra Assura™Unify Assura™Unify Quadra™UNIFY™Promote™Rivacor Rise HF-TRivacor Rise HF-T QPRivacor Aura HF-TRivacor Aura HF-T QPRivacor Sky HF-TRivacor Sky HF-T QPActicor Sky HF-T

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NIKDefibrillator, automatic implantable cardioverter, with card229
KRGProgrammer, pacemaker42
LWSImplantable cardioverter defibrillator (non-CRT)13
NVNDrug eluting permanent right ventricular (RV) or right atria6
NKEPulse generator, pacemaker, implantable, with cardiac resync6
LWPImplantable pulse generator, pacemaker (non-CRT)6

GMDN & GCC registration

  • GMDN code 47270 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 21

Use these as the dimensions to specify in a tender line.

How many cardiac resynchronization therapy implantable defibrillator products are registered in the US?

98 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac resynchronization therapy implantable defibrillator", from 5 companies. The largest labeler is St. Jude Medical, Inc. with 35% of records.

Which FDA product codes apply?

NIK (Defibrillator, automatic implantable cardioverter, with card), KRG (Programmer, pacemaker), LWS (Implantable cardioverter defibrillator (non-CRT)), NVN (Drug eluting permanent right ventricular (RV) or right atria)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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