14 results · 29ms · Sources: EU EUDAMED, US FDA

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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