11 results
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19ms
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Sources: EU EUDAMED, US FDA
VF LIQUIGEL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LiteTouch
FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730000794·LiteTouch Large Mask , ROW.
AUTION MAX AX-4280 URINALYSIS SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER
FDA 510(k)
FDA Class 1
·Physical Medicine
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018
12.0MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JDS·April 29, 2013
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·May 10, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·July 24, 2008
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024