24 results · 23ms · Sources: EU EUDAMED, 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