19 results · 37ms · Sources: EU EUDAMED, US FDA

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FORA GTel Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

UMBILI-CATH

FDA UDI
UTAH MEDICAL PRODUCTS, INC.·H67141735050·A Single-Lumen Silicone Umbilical Catheter, 3.5...

4173505

FDA Adverse Event
Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code FOS·May 30, 2000

4173505

FDA Adverse Event
Death ·UTAH MEDICAL PRODUCTS, INC.·Product code FOS·October 25, 2000

4173505

FDA Adverse Event
Injury ·Product code FOS·October 2, 2000

4173505

FDA Adverse Event
Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code FOS·October 25, 2000

MODIFICATION TO VALEO VBR

FDA 510(k)
FDA Class 2 ·Orthopedic

ALTUM ANTERIOR CERVICAL PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

BELLATEK® ABUTMENT TSV 3.5MM

FDA Adverse Event
Malfunction ·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026

ESON 2 NASAL MASK

FDA Adverse Event
Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

BELLATEK ABUTMENT TSV 4.5MM

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code NHA·February 5, 2021

UMBILI-CATH

FDA Adverse Event
Malfunction ·UTAH MEDICAL PRODUCTS INC.·Product code FOS·January 30, 2018

ABUTMENT, PATIENT SPECIFIC, TITANIUM

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·June 26, 2017

BELLATEK ABUTMENT TSV 4.5MM

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

BELLATEK ABUTMENT TSV 4.5MM

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

LAP-BAND ACCESS PORT KIT (UNK SIZE)

FDA Adverse Event
Malfunction ·ALLERGAN·Product code LTI·October 10, 2014

ENDO STITCH 10MM SUTURING DEVICE

FDA Adverse Event
Malfunction ·COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES·Product code KOG·June 12, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011

7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.

FDA Enforcement
Class II ·Terminated·Pentax of America Inc·July 26, 2017