8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
FDA 510(k)
FDA Class 1
·Hematology
Stern Snap One Piece Abutment 2mm Cuff (AJ)
FDA UDI
STERNGOLD DENTAL LLC·00841549113697·SternSnap Overdenture Implant Abutment System t...
GASTROSTOMY FEEDING CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MOBILIMB L4 LOWER LIMB CPM UNIT
FDA 510(k)
FDA Class 1
·Physical Medicine
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·January 9, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·November 22, 2010
FINELINE II
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code DTB·July 1, 2014
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