24 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LINK TrabecuLink Femoral Cones
FDA 510(k)
FDA Class 2
·Orthopedic
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003134·600 micron Holmium Laser Fiber Cable, Single Us...
24PW - Hanta Virus
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013442·Hanta Virus - 24 Poly White
FAA Airline - 24 Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013244·FAA Airline - 24 Poly White
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113981·HYDRO-DISSECT CANNULA 27GA ANGLED 8MM
MODIFICATION TO ENTEC PLASMA WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD DIRECTIGEN FLU A+B
FDA 510(k)
FDA Class 2
·Microbiology
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES (USA)·Product code HRS·March 10, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 9, 2013
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·October 14, 2008
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 26, 2013
SYNCHROMED
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·August 3, 2011
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·August 15, 2014
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 12, 2021
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·June 16, 2017
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·June 16, 2017
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024
WIRE, SURGICAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code LRN·April 25, 2017
TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy.
FDA Recall
Terminated
·TomoTherapy Incorporated·Product code IYE·February 22, 2008