14 results · 23ms · Sources: EU EUDAMED, US FDA

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Mg OSTEOREVIVE™, Mg OSTEOCRETE™

FDA 510(k)
FDA Class 2 ·Orthopedic

Evolve Stem

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051952·

Evolve Masters

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215002329·

PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code PMP·April 3, 2024

KIT IMPLANTABLE SLIM TIP LEAD, 50CM

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code PMP·April 3, 2024

HDS INTRA-ORAL IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Pico Way Laser System

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

KIT IMPLANTABLE SLIM TIP LEAD, 50CM

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code PMP·December 16, 2024

KIT IMPLANTABLE SLIM TIP LEAD, 50CM

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code PMP·October 28, 2024

KIT IMPLANTABLE SLIM TIP LEAD, 50CM

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code PMP·January 9, 2025

DUAL TRIGGER ROTARY

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·November 11, 2014

OT ULTRALINK METER

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

ACCU-CHEK ® SPIRIT COMBO

FDA Adverse Event
Injury ·ROCHE HEALTH SOLUTIONS, INC.·Product code LZG·July 23, 2013

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