13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083018450·STR, 10 electrode, MPD-S, 2-8-2-8-2-8-2-8-2mm e...
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06945664829281·Reusable SpO2 Sensor/Philips/Ear clip/Adult/1.1...
APK
FDA UDI
APK Technology Co.,Ltd.·06946725536711·Philips Compatible M1194A Adult Ear Clip SpO2 S...
NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
IMPROVACUTER GEL & CLOT ACTIVATOR TUBE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 30, 2014
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-CLONMEL·Product code MAF·November 20, 2010
CXDI CONTROL SOFTWARE NE VER. 1.40.2.0
FDA Adverse Event
Malfunction
·CANON, INC.-MEDICAL EQUIPMENT GROUP·Product code MQB·November 28, 2012
MEDTRONIC LEAD
FDA Adverse Event
Injury
·MEDTRONIC, PLC·Product code DXY·September 6, 2017
Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012