35 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VEEDA 100% COTTON MENSTRUAL TAMPON
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTRAMEDULLARY BONE PLUG
FDA UDI
Biomet Orthopedics, LLC·00880304005631·
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037302897·HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø36 +9
ZAVATION F3D-Z CIF
FDA UDI
Zavation LLC·00197157020712·F3D-Z CIF 14mmx18mmx9mm - 6deg
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037308233·TRIAL HUMERAL CUP 135/145° MOBILITY Ø36 +9
LINK Instruments - Wrenches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575229604·Surgical screwdriver, reusable - C.F.P. - Hip Stem
ALEUTIAN Interbody Systems
FDA UDI
VB Spine LLC·10888857560789·Disc Spreader Size 14 mm
EPIDUCER LEAD DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MODULEAF
FDA 510(k)
FDA Class 2
·Radiology
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 30, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 6, 2015
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·September 9, 2022
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 17, 2023
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