14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Meril-Bonewax
FDA 510(k)
FDA Unclassified
·Unknown
Intraoral Scan Body RP
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059075328·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016988·MFx™ 2.0mm Angulated Locking Drill Guide
MEDALLION(TM) MODULAR TRUNNION TRIAL
FDA UDI
Biomet Orthopedics, LLC·00880304640214·
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457209300·Conical BL
ACUMED
FDA UDI
Acumed LLC·10806378014109·3.5mm x 20.0mm Locking Cortical Screw
ACUMED
FDA UDI
Acumed LLC·10806378014116·3.5mm x 20.0mm Locking Cortical Screw
HIGH SILVER CONVENTIONAL
FDA 510(k)
FDA Class 2
·Dental
SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY AG·Product code MTA·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·July 1, 2013
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021