ClearanceBrief
Panels › Cardiovascular › Product code KRG · Class 3

Programmer, Pacemaker

Regulation 870.3700

0510(k)s in 12 months (25 all time)
0recalls in 12 months (11 all time)
0recalls that name a 510(k)
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Top companies in KRG

DateFirm and productCodeLinked 510(k)
Jul 17, 2025Medtronic, Inc.
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2.
Open, Classified
KRGNone listed
Jul 17, 2025Medtronic, Inc.
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percept
Open, Classified
KRGNone listed
Sep 29, 2016Sorin Group USA, Inc.
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurem
Terminated
KRGNone listed
Sep 29, 2016Sorin Group USA, Inc.
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement,
Terminated
KRGNone listed
Oct 7, 2010Boston Scientific CRM Corp
Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798.
Terminated
KRGNone listed
May 8, 2010Boston Scientific CRM Corp
VITALITY Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. AVT, model A155. VITALITY DS DR/VR (Models T125, T135), VITALITY 2 DR/VR (Models T165, T175) and VITALITY 2 EL
Terminated
KRGNone listed
Dec 19, 2006St Jude Medical CRMD
St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
Terminated
KRGNone listed
Dec 19, 2006St Jude Medical CRMD
St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
Terminated
KRGNone listed
Sep 28, 2006Boston Scientific CRM Corp
Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation
Terminated
KRGNone listed
Aug 3, 2005Guidant Corporation
PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue
Terminated
KRGNone listed
Jun 30, 2005Guidant Corporation
Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Ha
Terminated
KRGNone listed

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