11 results · 31ms · Sources: EU EUDAMED, US FDA

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STRAUMANN WN CARES TITANIUM ABUTMENT

FDA 510(k)
FDA Class 2 ·Dental

7F LAUNCHER GUIDE CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR

FDA 510(k)
FDA Class 2 ·Orthopedic

ASR ACETABULAR IMPLANT 48

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·April 29, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·April 28, 2011

MULTI-LINK RX VISION CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·July 24, 2008

HEARTMATE 14 VOLT LITHIUM ION BATTERY SET

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·February 26, 2024

HEARTMATE 3 TUNNELING LANCE AND HANDLE

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·December 13, 2024

PEEK CAGE, UNKNOWN TYPE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·February 9, 2021

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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