10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
GCII AGAR WITH ISOVITALX(R) ENRICHMENT
FDA 510(k)
FDA Class 2
·Microbiology
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
UMBILICAL CLAMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
FDA 510(k)
FDA Class 2
·Neurology
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 6, 2013
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·December 10, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 21, 2014
PKG, PKG, HOOK SCISSORS, P/N 0250080260. 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