27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRIGEN LOW PROFILE BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
Batrik Non-Sterile Suture Tags Assort
FDA UDI
Batrik Medical Manufacturing Inc·00690521011052·"Suture Clamp Tags, Radio Opaque, Non-Sterile, ...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311110250·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321110250·
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981063184·ROD, 6.35 x 250MM
Batrik Suture Clamp Tags
FDA UDI
Batrik Medical Manufacturing Inc·00690521014374·Suture Clamp Tags, Radio Opaque, Sterile, Assor...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197541732·Ferreira Style Breast Retractor
110x25...
FORTAFLEX SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SECTRA MICRODOSE MAMMOGRAPHY
FDA 510(k)
FDA Class 2
·Radiology
EVIS LUCERA ELITE DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDT·August 9, 2022
20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·October 26, 2016
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 14, 2013
ALENTI
FDA Adverse Event
Other
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·May 10, 2011
MULTIFIRE ENDO GIA 30-2.5 (V) 12MM STAPLE
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·August 12, 2008
SINGLE USE DISTAL COVER
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT·Product code FDT·August 9, 2022
TRI-STAPLE 2.0
FDA Adverse Event
Malfunction
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 13, 2024
LIBRE 2 SENSOR FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code QLG·February 9, 2024
Portex Tracheal Tube, Oral/Nasal, Siliconized, 2.5 mm Product Code: 100/111/025. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Recall
Open, Classified
·Smiths Medical ASD, Inc.·Product code BTR·February 13, 2025
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025