11 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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