17 results · 21ms · Sources: EU EUDAMED, US FDA

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CALIBER SPACERS

FDA 510(k)
FDA Class 2 ·Orthopedic

SBH

FDA UDI
SBH Surgical·00850068304011·1/1, Sterilization Container Perforated Lid, Bl...

ArgenPMMA 98x30-A0

FDA UDI
ARGEN CORPORATION, THE·D818123231·Crown And Bridge, Temporary, Resin

ELFCARE DEVICE, MODELS 314A THROUGH 314G

FDA 510(k)
FDA Class 2 ·Neurology

KYPHON INFLATION SYRINGE

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 20, 2025

BD PHASEAL¿ INJECTOR LUER LOCK N35C

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
CONSMA·Product code ITJ·May 21, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

RADIAL JAW 4 BIOPSY FORCEPS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·June 14, 2011

TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code MRG·April 19, 2018

BD PHASEAL¿ CONNECTOR LUER LOCK (C35)

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019

Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

FDA Enforcement
Class II ·Terminated·Amendia, Inc·December 28, 2016

Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

Artis Q.zen biplane, Model Number 10848355

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017