13 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ML24000 UVA-1 PHOTOTHERAPY CABINET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sami the Seal
FDA UDI
VEGA TECHNOLOGIES INC.·06946159501064·1082731
N LATEX B2-MICROGLOBULIN
FDA 510(k)
FDA Class 2
·Immunology
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
RADIFOCUS OPTITORQUE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 29, 2013
IUNI G2
FDA Adverse Event
Injury
·CONFORMIS·Product code HSX·April 28, 2011
PUMP MMT-522NAL PRDGM INS V2.2 CL EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·July 23, 2008
HEARTMATE 3 VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·March 30, 2021
PRESIDIO 10 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
PRESIDIO 18 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
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