28 results · 23ms · Sources: EU EUDAMED, US FDA

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All-Bond Universal w/BAC (not finalized)

FDA 510(k)
FDA Class 2 ·Dental

AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX

FDA 510(k)
FDA Class 2 ·Orthopedic

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER

FDA 510(k)
FDA Class 2 ·Radiology

CARELINK

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

ACCESS 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 17, 2011

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 28, 2023

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·May 7, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·August 21, 2023

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL, INC.·Product code KRD·November 19, 2021

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 16, 2024

UNIVERSA SOFT URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·January 29, 2019

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 27, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL·Product code KRD·October 1, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL, INC.·Product code KRD·June 19, 2025

UNIVERSA SOFT URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

UNIVERSA SOFT URETERAL STENT SET

FDA Adverse Event
Injury ·COOK INC·Product code FAD·September 8, 2016