14 results
·
20ms
·
Sources: EU EUDAMED, US FDA
VITALA CONTINENCE CONTROL DEVICE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
LiteTouch
FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730000749·LiteTouch Small Mask - ROW.
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
FDA 510(k)
FDA Class 2
·Radiology
UROVYSION BLADDER CANCER RECURRENCE KIT
FDA 510(k)
FDA Class 2
·Immunology
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 9, 2025
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·May 6, 2010
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·November 5, 2010
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·November 25, 2010
CLAMP HOLDER FOR USS ILIOSACRAL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·April 29, 2013
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·May 10, 2011
GE OEC 2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 29, 2008
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 10, 2024
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