23 results
·
24ms
·
Sources: EU EUDAMED, US FDA
IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDOSKELETON TC
FDA 510(k)
FDA Class 2
·Orthopedic
BABY DOPPLEX 3000 MK 2 (BD3000)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 21, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 21, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMP,TSV,MCOL MG,3.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 23, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 1, 2023
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 14, 2013
6FR FEEDING TUBE
FDA Adverse Event
Malfunction
·VYGON·Product code FPD·May 13, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·August 12, 2008
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·December 14, 2022
BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·January 2, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·June 16, 2022
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 9, 2025
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·December 20, 2022
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 27, 2024
IMP,TSV,MCOL MG,4.7MM,13M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 20, 2023
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code DZE·February 13, 2019
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024