15 results
·
31ms
·
Sources: EU EUDAMED, US FDA
CHEETAH RELIANT
FDA 510(k)
FDA Class 2
·Cardiovascular
LEONE SPA
FDA UDI
LEONE SPA·08033707065807·EXTRAORAL ELASTIC KIT
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MILLENIA PTCA CATHETER
FDA Adverse Event
Malfunction
·MEDTRONICS INTERVENTIONAL VASCULAR·Product code LOX·June 4, 1997
MILLENIA PTCA CATHETER
FDA Adverse Event
Malfunction
·MEDTRONICS INTERVENTIONAL VASCULAR·Product code LOX·June 4, 1997
MILLENIA PTCA CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC INTERVENTIONAL VASCULAR·Product code LOX·April 7, 1997
MILLENIA PTCA CATHETER
FDA Adverse Event
Malfunction
·MEDTRONICS INTERVENTIONAL VASCULAR·Product code LOX·April 7, 1997
REBOUND HRD
FDA Adverse Event
Malfunction
·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011
X3 TRIATHLON CS INS SIZE4 11MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 29, 2013
FOLEY CATH SIL-ELASTOMER 30FR
FDA Adverse Event
Other
·Product code KOD·April 28, 2011
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·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
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022