12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
FDA 510(k)
FDA Class 1
·Microbiology
Modular Bio-Core Tap
FDA UDI
Biomet Orthopedics, LLC·00887868567698·
7MM MODULAR BIO-CORE TAP
FDA UDI
Biomet Orthopedics, LLC·00880304480216·
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746100437·DB BKT MASTER LR CUSP 022 T=0 A+5 R=0
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482129791·Symmetry® Needle; Puncture; 5 mm Diameter; 12 G...
INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT
FDA 510(k)
FDA Class 2
·Hematology
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·January 9, 2013
CURVTEK CARTRIDGE 7MM MEDIUM
FDA Adverse Event
Malfunction
·BIOMET SPORTS MEDICINE·Product code HSZ·November 22, 2010
CARE ASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·June 10, 2014
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024