11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517566409·CoRoent Ant TLIF PEEK, 15x12x28mm 4°
REFORMAT GATEWAY
FDA 510(k)
FDA Class 2
·Radiology
KRYSTALRAD 560 (FLAATZ 560)
FDA 510(k)
FDA Class 2
·Radiology
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·April 22, 2020
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
FDA Adverse Event
Malfunction
·MEDTRONIC SINGAPORE OPERATIONS·Product code NVN·June 7, 2013
ASAHI PROWATER PTCA GUIDE WIRE
FDA Adverse Event
Injury
·AV-ASAHI·Product code DQX·July 7, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·March 21, 2022
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023