ClearanceBrief
Product code OSR ยท Class 3

Pacemaker/Icd/Crt Non-Implanted Components

0510(k)s in 12 months (0 all time)
0recalls in 12 months (15 all time)
0recalls that name a 510(k)
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Top companies in OSR

DateFirm and productCodeLinked 510(k)
Mar 10, 2022St. Jude Medical, Cardiac Rhythm Management Division
Merlin PCS 3650 programmer Model 3330 software
Open, Classified
OSRNone listed
Oct 12, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization
Open, Classified
OSRNone listed
Apr 6, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Open, Classified
OSRNone listed
Jan 30, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Open, Classified
OSRNone listed
Jan 30, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Open, Classified
OSRNone listed
Oct 3, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
Open, Classified
OSRNone listed
Oct 3, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
Open, Classified
OSRNone listed
Oct 3, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Open, Classified
OSRNone listed
Jan 17, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Terminated
OSRNone listed
Jan 17, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
Terminated
OSRNone listed
Jan 17, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
MEDTRONIC CARELINK 2090 programmer
Terminated
OSRNone listed
Oct 2, 2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic CareLink Encore 29901 Programmer
Open, Classified
OSRNone listed
Oct 2, 2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic CareLink 2090 Programmer
Open, Classified
OSRNone listed
Apr 16, 2018St Jude Medical Inc.
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Terminated
OSRNone listed
Aug 28, 2017St Jude Medical Inc.
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care Sy
Terminated
OSRNone listed

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