124 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTRODUCER SETS, MODEL ADELANTE RADIAL
FDA 510(k)
FDA Class 2
·Cardiovascular
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197048392·Walter-Carmalt Splinter Forceps
curved...
MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
FDA 510(k)
FDA Class 2
·Dental
PFNA BLADE PERF L95 SST
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·May 24, 2013
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HSB·September 30, 2014
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
INSPIRE 6F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·December 26, 2012
RESERVOIR INSPIRE 8
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026
INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025
INSPIRE HARD VENOUS RESERVOIR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022
INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·January 13, 2023
INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES
FDA Adverse Event
SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 19, 2016
INSPIRE HVR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·July 21, 2022
INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 5, 2019
INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTZ·October 5, 2016
INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOT
FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTZ·November 4, 2016
INSPIRE 6M HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER HARDSHELL VEN/CARD RES
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 6, 2016
INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VEN/CARDIOTOMY RESERV
FDA Adverse Event
Malfunction
·SORIN GROUP ITALI SRL·Product code DTZ·October 20, 2016