14 results
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29ms
·
Sources: EU EUDAMED, US FDA
ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER
FDA 510(k)
FDA Class 2
·General Hospital
ANA/HEp-2 IgG IFA 96 Test
FDA UDI
Hemagen Diagnostics, Inc.·G5229023441·For the detection and titration of anti-nuclear...
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113356·CLEAR CORNEA KNIFE 2.8MM (BX/5)
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
LAC-MAC INNERBLOC LR SURGICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 30, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 8, 2013
31G X 8MM PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FMI·November 12, 2010
WITTICH NITINOL STONE BASKET
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·February 20, 2019
WITTICH NITINOL STONE BASKET
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·February 20, 2019
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025