10 results · 19ms · Sources: EU EUDAMED, US FDA

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Colorado Therapeutics Xenograft Implant

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

OSTEOPHIL BETA-TCP

FDA 510(k)
FDA Class 2 ·Orthopedic

EASYTRAK 2

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·July 22, 2011

GOBED II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 17, 2013

CLARION

FDA Adverse Event
Malfunction ·ADVANCED BIONICS LLC·Product code MCM·September 19, 2008

DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

FDA Adverse Event
Injury ·COOK INC·Product code DQO·August 10, 2023

Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.

FDA Enforcement
Class II ·Terminated·PSC Industries Inc·July 18, 2012

Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

FDA Enforcement
Class II ·Terminated·Ecolab Inc·October 31, 2018

Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.

FDA Recall
Terminated ·PSC Industries Inc·Product code GEI·June 1, 2012