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