8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS
FDA 510(k)
FDA Class 2
·Anesthesiology
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
FDA 510(k)
FDA Class 2
·General Hospital
BLACKSTONE POSTERIOR CERVICAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD PHASEAL PROTECTOR P50J
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·July 7, 2023
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 23, 2014
M2A-MAGNUM 42-50MM TPR INSRT-6
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 13, 2012
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV·Product code FNL·September 2, 2010
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022