8 results · 20ms · Sources: EU EUDAMED, US FDA

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VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens

FDA 510(k)
FDA Class 2 ·Ophthalmic

TITAN Modular Total Shoulder System

FDA 510(k)
FDA Class 2 ·Orthopedic

ACS MODEL NCP-2

FDA 510(k)
FDA Class 2 ·Cardiovascular

HARMONIC ACE 36CM W ERG HANDLE

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC·Product code LFL·November 24, 2008

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·September 10, 2011

11CM ANGLE ATTACHMENT, BLACK MAX

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 23, 2013

TMC SPEEDMTP

FDA Adverse Event
Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025

UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

FDA Enforcement
Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014