10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
RPM RESPIRATORY GATING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TI-DBLE LEAD CORT SCR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·August 24, 2018
PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067
FDA 510(k)
FDA Class 2
·Radiology
SAS STREPALERT
FDA 510(k)
FDA Class 1
·Microbiology
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 26, 2013
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·March 22, 2011
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·June 18, 2008
Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
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 Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015