15 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NervAlign Nerve Cuff
FDA UDI
RENERVE LIMITED·09369998075812·An absorbable collagen membrane implant that pr...
NervAlign Nerve Cuff
FDA UDI
RENERVE LIMITED·09369998146796·An absorbable collagen membrane implant that pr...
NervAlign Nerve Cuff
FDA UDI
RENERVE LIMITED·09369998231904·An absorbable collagen membrane implant that pr...
ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
FDA Enforcement
Class II
·Terminated·Volcano Corp·July 15, 2015
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
FDA Enforcement
Class II
·Terminated·Volcano Corp·July 15, 2015
Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
FDA Enforcement
Class II
·Terminated·Volcano Corp·July 15, 2015
NEUROPACE RNS SYSTEM
FDA Adverse Event
Injury
·NEUROPACE, INC.·Product code PFN·March 16, 2026
INTELLIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 22, 2020
ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
FDA Recall
Terminated
·Volcano Corp·Product code IYO·September 23, 2013
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
FDA Recall
Terminated
·Volcano Corp·Product code IYO·September 23, 2013
Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
FDA Recall
Terminated
·Volcano Corp·Product code IYO·September 23, 2013
Actical with Step, Part Number 198-0302-00, Mini Mitter, a Respironics Company, Bend, Oregon
FDA Recall
Terminated
·Mini-Mitter Company, Inc.·Product code M·June 27, 2007
Actiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup pkg Part Number 198-1000-00.
FDA Recall
Terminated
·Mini-Mitter Company, Inc.·Product code M·June 27, 2007
Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company, Bend, Oregon
FDA Recall
Terminated
·Mini-Mitter Company, Inc.·Product code M·June 27, 2007
Actiwatch 16 Part Number 198-0300-00, Actiwatch 16 AM 198-0300-AM; Actiwatch 64 Part Number 198-0301-00; Actiwatch 64 AM Part Number 198-0301-AM, Mini Mitter, a Respironics Company, Bend, Oregon
FDA Recall
Terminated
·Mini-Mitter Company, Inc.·Product code M·June 27, 2007