10 results · 25ms · Sources: EU EUDAMED, US FDA

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MESIAL LOOP BAR

FDA 510(k)
FDA Class 1 ·Dental

ZAVATION

FDA UDI
Zavation LLC·00842166190757·Polyaxial Reduction Screw 3.5x42

EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

PURACYN PLUS SKIN AND WOUND

FDA 510(k)
FDA Unclassified ·Unknown

INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·January 29, 2013

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 21, 2010

DEPUY ASR XL FEM IMP SIZE 49

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·July 15, 2014

BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·January 4, 2022

Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·March 13, 2019

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021