11 results · 22ms · Sources: EU EUDAMED, US FDA

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BEACON STABILIZATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NOBELREPLACE CC PMC RP 4.3X10MM

FDA Adverse Event
Injury ·NOBEL BIOCARE USA INC·Product code DZE·June 15, 2021

NOBELPARALLEL CC NP 3.75X13MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·March 8, 2021

NOBELPARALLEL CC NP 3.75X13MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·March 8, 2021

PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS

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

LEAD MODEL 302

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·April 23, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·April 29, 2011

RIATA ST OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

FDA Enforcement
Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012