16 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DMA TRIGLYCERIDE (GPO) PROCEDURE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814657·GENUMEDI SILVER SIZE II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257024379·OMOMED SHOULDER SUP SILVER LEFT SIZE II
36M - Salt River Project-31 - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588022024·36M - Salt River Project-31 - Metal
Rampart One Lumbar Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7404902202·Rampart One Oblique Trial, 12mm, S, 8°
BONE-LOK MVP Cortical-Cancellous Compression Device
FDA UDI
INTERVENTIONAL SPINE, INC·81195401192562·3.5mm Diameter x 40-50mm Length
SAFESTEP 20G X 3/4 STRAIGHT
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code FPA·June 26, 2009
KARMAN WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT
FDA 510(k)
FDA Class 2
·Physical Medicine
SOMATOM DEFINITION FLASH
FDA Adverse Event
Death
·SIEMENS HEALTHCARE GMBH·Product code JAK·December 22, 2020
SYRINGE 20ML W/O
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·August 8, 2019
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FMI·June 23, 2014
PIPELINE EMBOLIZATION PROCEDURE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code HCG·January 8, 2013
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·November 15, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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