12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PCA-8000A, MARK 11, PET / CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INFINION? CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 9, 2025
GAMMA 3 NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
G-1 VERSION 3, MODEL 10048
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
FDA Adverse Event
Other
·SORIN GROUP, DEUTSCHLAND·Product code DXC·April 15, 2010
CORTSCR Ø2 SELF-DRILL L6 TAN
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code MQN·April 29, 2013
ECHELON*FLEX60
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·May 9, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 22, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018