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

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WAVE Clinical Platform

FDA 510(k)
FDA Class 2 ·Cardiovascular

NEUTROPHASE WOUND CLEANSER

FDA 510(k)
FDA Unclassified ·Unknown

VARIAX ELBOW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BIZACT

FDA Adverse Event
Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·June 18, 2019

CUSTOM PROXIMAL FEMUR IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014

CUSTOMER PROXIMAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Injury ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014

REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 11, 2022

THREADED GLENOID BASEPLATE

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 5, 2025

CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code JWH·January 8, 2015

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 14, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·June 14, 2013

TERUMO ADVANCED PERFUSION SYSTEM 1

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·July 1, 2011

CUSTOM DISTAL FEMORAL IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014

UNK- NON- STANMORE HIP REPLACEMENT IMPLANT

FDA Adverse Event
Malfunction ·UNKNOWN·Product code KRO·June 25, 2015

CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014

PROXIMAL FEMUR

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 19, 2014

CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·July 1, 2015

CUSTOM MID-SHAFT FEMUR

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 23, 2014

Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

FDA Enforcement
Class II ·Completed·Hologic, Inc·December 18, 2024

DISTAL FEMUR JTS IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 19, 2014