12 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SPIRO-FLEX
FDA 510(k)
FDA Class 1
·Anesthesiology
Ophthalmic Scissors
FDA UDI
KATENA PRODUCTS, INC.·00841668105788·STOLTE SOFT IOL CUTTER
IMMOBILE
FDA 510(k)
FDA Class 1
·General Hospital
LATERAL BUTTRESS SUPPORT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·February 6, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 4, 2011
PARADIGM REAL-TIME 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, 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
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology