10 results
·
34ms
·
Sources: EU EUDAMED, US FDA
ALTRES(R) 140 HEMODIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD
FDA 510(k)
FDA Class 2
·Orthopedic
NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST
FDA 510(k)
FDA Class 2
·Neurology
PROCEED VENTRAL PATCH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·December 27, 2010
PROLIFT +M PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·February 6, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 21, 2014
BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿)
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·July 15, 2022
BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿), PLATE, 90 MM X 120
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·March 29, 2022
PLATE CHOCO GC AGAR W/ISOVITALEX 90MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·June 1, 2021
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014