13 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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