14 results · 30ms · Sources: EU EUDAMED, US FDA

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SMV Scientific Cannulated Screws

FDA 510(k)
FDA Class 2 ·Orthopedic

Symetri Clear

FDA UDI
ORMCO CORPORATION·00889989083422·SYMETRI CLEAR TYPODONT - MCLAUGHLIN, BENNETT, T...

LEONE SPA

FDA UDI
LEONE SPA·08033707018087·CALIBRA 1ST MOLAR BANDS n.LL 21

Paltop

FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695656·Dynamic Dental Implant Ø3.25mm L16mm

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690190103·Back table tibial tray assembler 1-3

ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0

FDA 510(k)
FDA Class 2 ·Orthopedic

DASH HIP

FDA 510(k)
FDA Class 2 ·Neurology

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 14, 2014

MINICAP TRANSFER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 14, 2013

ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code NIQ·July 15, 2011

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 4, 2026

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·September 26, 2019

Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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