14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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