31 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SILVERVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948002683·SILVERVENT Jatho 2 IC, SIZE 9
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023925·PADDLE SPREADER, 9MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102090·Shaver, Open 9mm
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DOSE 1
FDA 510(k)
FDA Class 2
·Radiology
GF-210RA
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORP·Product code CCK·February 2, 2015
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 2, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 7, 2011
UNK DEPUY TIBIAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSH·April 16, 2008
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 10, 2019
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 10, 2017
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·August 3, 2022
INSPIRE 6 HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·February 25, 2022
INSPIRE 6
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL.·Product code DTZ·July 15, 2024
INSPIRE 6F M DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 17, 2018
INSPIRE 6F DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VEN/CARD RES
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 24, 2018