23 results · 24ms · Sources: EU EUDAMED, US FDA

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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