9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LYMA Laser PRO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Syntec-Taichung Non-sterile Bone Plate and Screw Implants
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04719864684467·L & T-Plate(Left Obliqre) 2.0
Sklar®
FDA UDI
SKLAR CORPORATION·10649111137822·BEEBEE CROWN SCISS BL STR 4"
POLYPROPILENE SURGICAL SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BruxZir Anterior
FDA 510(k)
FDA Class 2
·Dental
FIRE STAR RX PTCA BALLOON CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code LOX·September 12, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014
MONOCRYL PLUS SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·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