14 results
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23ms
·
Sources: EU EUDAMED, US FDA
INVISALIGN SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Centaur Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215126810·
RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 2, 2024
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 11, 2021
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 5, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·July 23, 2008
PROXIMAL HUMERUS, LEFT, 9X160MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code HSB·September 27, 2022
BLUNT TIP SCREW, 4X34MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code HSB·September 27, 2022
BLUNT TIP SCREW, 4X36MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code HSB·September 27, 2022
BLUNT TIP SCREW, 4X34MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code HSB·September 27, 2022
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 1, 2016