18 results · 28ms · Sources: EU EUDAMED, US FDA

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Armada™ 14 NC PTA Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

Darby Dental Supply, LLC

FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813052891·NITI ROTARY FILE S17/T04 25MM DARBY

INTUITION

FDA UDI
DEPUY (IRELAND)·10603295550822·INTUITION FOR HP PARTIAL METAL SPACER SIZE 2 ...

devemed

FDA UDI
devemed GmbH·04061644037933·Periodontal Probe # 23/CP15 graduated; 1-2...-1...

Trigon

FDA UDI
NVISION BIOMEDICAL TECHNOLOGIES, INC.·00810005669320·Implant PEEK CC Wedge, 12mm. The Trigon HA Sta...

INTUITION

FDA UDI
DEPUY (IRELAND)·10603295550839·INTUITION FOR HP PARTIAL METAL SPACER SIZE 2 ...

INTUITION

FDA UDI
DEPUY (IRELAND)·10603295545101·INTUITION FOR HP PARTIAL SPACER SIZE 1-2 11mm

ceraMotion®

FDA UDI
DENTAURUM GmbH & Co.KG·J011252512030·ceraMotion® Me Paste Opaque C3, 3g / dental c...

Half Dome Posterior Lumbar Interbody System

FDA 510(k)
FDA Class 2 ·Orthopedic

G7® Vivacit-E® Freedom® Constrained Liner

FDA 510(k)
FDA Class 2 ·Orthopedic

NA

FDA UDI
Exactech, Inc.·10885862524317·TRIAL, TIBIAL INSERT, SPACER, SIZE 5, SIZE 6, 12mm

Reicodent

FDA UDI
devemed GmbH·04061644062799·Periodontal Probe # 23/CP15 graduated; 1-2...-1...

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 17, 2011

PUMP IN STYLE (ITEM # UNK)

FDA Adverse Event
Malfunction ·MEDELA, INC.·Product code HGX·July 24, 2013

Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover Component: Lumicell Direct Visualization System (DVS) / PMA # P230014

FDA Enforcement
Class II ·Ongoing·Lumicell, Inc.·September 10, 2025

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014