10 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
FDA 510(k)
FDA Class 2
·Neurology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113837·VISCO CANNULA 23GA ANGLE 8MM
STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
TVC IMAGING SYSTEM MODEL NIRS-MC7-70
FDA 510(k)
FDA Class 2
·Cardiovascular
PARIETEX UGYTEX PP ANTERIOR KIT X1
FDA Adverse Event
Injury
·TREVOUX - USS·Product code FTL·June 20, 2009
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
SUREFIT
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code GEI·August 19, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018