17 results
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18ms
·
Sources: EU EUDAMED, US FDA
UROTOPO CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PREMIER(TM) Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902688362·PLATE 6861200 100MM ANTERIOR CERVICAL
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190691·Femoral Repostioning Block
Orthodontic Wax
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746035074·SUPPLIES - ORTHODONTIC WAX 100/PKG
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746034893·SUPPLIES - ORTHODONTIC WAX 100/PKG
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746162138·SUPPLIES - ORTHODONTIC WAX 100/PKG
ENZYMATIC TRIGLYCERIDES (END POINT)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
FDA 510(k)
FDA Class 2
·Anesthesiology
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 4, 2010
CUSTOM QUICK CONNECT THREADED
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·November 2, 2012
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 17, 2016
Vanguard XP Tibial Tray 71 mm Item # 195249
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. Product is labeled in part: "***REF 915-3100 LOT***LACTOSORB* SYSTEM HEAT/CONTOURING PEN AND TIPS***QTY 00001***STERILE R STERILE EO***PVC, BRASS***WARNING: DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS. FIRE COULD RESULT.***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA***#915-3100 LOT***QTY 00001, HEAT/CONTOURING PEN AND TIPS***PVC, BRASS***". Product Usage: Two tips are provided with the body of the device to cut / contour the edges of the LactoSorb plates by heating the material.
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code IRQ·November 15, 2011
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012