8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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