22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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5.5 F Worley Advanced LVI Lateral Vein Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169502291·INTERBODY 2152116 SMALL - 12 DEG 16MM
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283662·MEYERDING FINGER RETRACTOR #1 7"
LLD EZ
FDA 510(k)
FDA Class 2
·Cardiovascular
DIGITAL CLINICAL THERMOMETER MODEL V901US
FDA 510(k)
FDA Class 2
·General Hospital
CIRCLIP PSO-K
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JDI·May 26, 2017
TIBIAL REVISION COMP.72MM -L-
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·May 26, 2017
TIBIAL PIN 34MM PSO-K
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·May 26, 2017
FEM.REVISION COMP.64MM IZDA-M-
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·May 26, 2017
TIBIAL INSERT 14MM -L-
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·May 26, 2017
STRAIGHT STEM 11.5X210MM PSO-R
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·May 26, 2017
STRAIGHT STEM 13X80MM PSO-R
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·May 26, 2017
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 7, 2011
MICROSENSOR VENTRICULAR CATHETER KIT
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF·Product code GWM·October 8, 2014
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 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
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024