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