23 results · 30ms · Sources: EU EUDAMED, US FDA

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BRX PRO Bruxism Guard

FDA 510(k)
FDA Unclassified ·Unknown

EXPASYL POWER APPLICATOR

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO:EXPEDIUM SPINE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAT·August 14, 2018

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Malfunction ·LDR MEDICAL·Product code OVE·February 4, 2020

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code OVE·April 13, 2020

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM

FDA Adverse Event
Malfunction ·LDR MEDICAL·Product code OVE·August 6, 2020

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA INC.·Product code LWP·June 7, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

VERSACARE

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

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code OVE·August 24, 2021

SPACER, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MEDICAL·Product code ODP·August 23, 2019

CONQUEST PRO 12 ST

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code OVE·September 21, 2021

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X15,5MM

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code OVE·August 17, 2022

ASTATO XS 9-12

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 21, 2018

ECHELON ENDOPATH STAPLER

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 21, 2018

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 20, 2013

SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 26, 2014