12 results · 26ms · Sources: EU EUDAMED, US FDA

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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