10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
FDA 510(k)
FDA Class 2
·General Hospital
IRADIMED
FDA Adverse Event
Malfunction
·IRADIMED CORP.·Product code FRN·December 11, 2019
DIRECT BILIRUBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 27, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·March 18, 2011
NOVOPEN 3
FDA Adverse Event
NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·March 14, 2008
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018