19 results
·
37ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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