23 results · 29ms · Sources: EU EUDAMED, US FDA

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AVT NATURASOFT

FDA 510(k)
FDA Class 2 ·Ophthalmic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517577252·CoRoent Ant TLIF PEEK, 12x11x32mm 4°

Z Liquid HT C2-S 100ml

FDA UDI
ARGEN CORPORATION, THE·D818121324·Dental porcelain/ceramic restoration kit

TASMIN R 12°

FDA UDI
SIGNUS Medizintechnik GmbH·04047844014967·The basic shape of the TASMIN R devices is a ho...

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515016613·Hegar NH, stubby jaw, 8"

GE ECHOPAC MODEL BT10

FDA 510(k)
FDA Class 2 ·Radiology

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)

FDA 510(k)
FDA Class 2 ·Orthopedic

ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code ORG·March 5, 2019

ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code ORG·May 1, 2019

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

ALARIS SYSTEM PUMP MODULE

FDA Adverse Event
Other ·CARDINAL HEALTH ALARIS PRODUCTS·Product code FRN·August 13, 2008

TOTAL ASR ACET IMP SIZE 58

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 1, 2011

ARCHITECT B12 REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·April 17, 2025

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·September 29, 2023

ALINITY I B12 REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·January 27, 2025

ALINITY I B12 REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·September 22, 2025

ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system 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 zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 21, 2018

Artis Q biplane, Model Number 10848282

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

XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4, Ref: X098-0108-STR DI Number: M697X0980108STR1 Mat.: CP Ti Grade 5, Ref: X098-0109-STR DI Number: M697X0980109STR1 Mat.: CP Ti Grade 6, Ref: X098-0110-STR DI Number: M697X0980110STR1 Mat.: CP Ti Grade 7, Ref: X098-0111-STR DI Number: M697X0980111STR1 Mat.: CP Ti Grade 8, Ref: X098-0112-STR DI Number: M697X0980112STR1 Mat.: CP Ti Grade 9, Ref: X098-0205-STR DI Number: M697X0980205STR1 Mat.: CP Ti Grade 10, Ref: X098-0206-STR DI Number: M697X0980206STR1 Mat.: CP Ti Grade 11, Ref: X098-0207-STR DI Number: M697X0980207STR1 Mat.: CP Ti Grade 12, Ref: X098-0208-STR DI Number: M697X0980208STR1 Mat.: CP Ti Grade 13, Ref: X098-0209-STR DI Number: M697X0980209STR1 Mat.: CP Ti Grade 14, Ref: X098-0210-STR DI Number: M697X0980210STR1 Mat.: CP Ti Grade 15, Ref: X098-0211-STR DI Number: M697X0980211STR1 Mat.: CP Ti Grade 16, Ref: X098-0212-STR DI Number: M697X0980212STR1 Mat.: CP Ti Grade 17, Ref: X098-0305-STR DI Number: M697X0980305STR1 Mat.: CP Ti Grade 18, Ref: X098-0306-STR DI Number: M697X0980306STR1 Mat.: CP Ti Grade 19, Ref: X098-0307-STR DI Number: M697X0980307STR1 Mat.: CP Ti Grade 20, Ref: X098-0308-STR DI Number: M697X0980308STR1 Mat.: CP Ti Grade 21, Ref: X098-0309-STR DI Number: M697X0980309STR1 Mat.: CP Ti Grade 22, Ref: X098-0310-STR DI Number: M697X0980310STR1 Mat.: CP Ti Grade 23, Ref: X098-0311-STR DI Number: M697X0980311STR1 Mat.: CP Ti Grade 24, Ref: X098-0312-STR DI Number: M697X0980312STR1 Mat.: CP Ti Grade 25

FDA Enforcement
Class III ·Terminated·XTANT Medical·November 18, 2020

Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018