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

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Amia Automated PD System with Sharesource

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

AMIA AUTOMATED PD CYCLER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020

AMIA AUTOMATED PD CYCLER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023

AMIA AUTOMATED PD CYCLER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024

XENMATRIX

FDA UDI
Davol Inc.·00801741074257·XenMatrix AB Surgical Graft, 15 cm x 25 cm

BONE SCREW, CORTICAL

FDA UDI
Biomet Orthopedics, LLC·00887868004674·

ProLift Trial

FDA UDI
Life Spine, Inc.·00190837088552·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167311515250·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321515250·

Canaveral®

FDA UDI
FLOSPINE LLC·B183115150250·Reduction Monoaxial Screw, 10.5mm x 25mm

ARX SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PIONEER SPINOUS PROCESS FUSION PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

REVO MRI SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·June 7, 2013

ENDOTAK DSP

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 6, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

TR BAND

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

TR BAND

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

TI QUARTER-TUBULAR PLATE WITH COLLAR 7 HOLES/55MM

FDA Adverse Event
Injury ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HRS·January 2, 2018

iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

Medical Linear Accelerator

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 14, 2016