24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Y2000 POCKET RESCUE
FDA 510(k)
FDA Class 2
·Anesthesiology
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964055285·Endo Carry-on Procedure Kit Includes Basin, Int...
106 Syringe
FDA UDI
M DIALYSIS INC.·07332699000072·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101110·Distractor, Smooth Paddle, 11mm
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101110·Distractor, Smooth Paddle, Lordotic, 11mm
GeniShield
FDA UDI
GENICON, INC.·00877972000532·
INSET I
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 14, 2025
INSET I
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 14, 2025
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EEG WITH VIDEO, MODEL EX-NW
FDA 510(k)
FDA Class 2
·Neurology
ENDOPATH DISPOSABLE SURGICAL TROCAR
FDA Adverse Event
Malfunction
·EES-JUAREZ·Product code GCJ·December 18, 1996
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 24, 2022
TI PSPC MATRIXMANDIBLE 20H PL 2.0MM THICK
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code JEY·March 19, 2013
MA204
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 1, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·March 10, 2008
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·February 12, 2019
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·February 12, 2019
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·February 12, 2019
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020
BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020