1,061 results · 27ms · Sources: EU EUDAMED, US FDA

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2300 SERIES MGO PORTABLE OXYGEN

FDA 510(k)
FDA Class 2 ·Anesthesiology

EVIS EXERA DUODENOVIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDT·March 1, 2024

EVIS EXERA DUODENOVIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDT·March 1, 2024

EVIS EXERA DUODENOVIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDT·March 1, 2024

EVIS EXERA II DUODENOVIDEOSCOPE

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·April 18, 2021

ESSURE (ESS205)

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·July 29, 2025

AVENTIS PHARMACEUTICAL PRODUCT INC.

FDA Adverse Event
Malfunction ·MFD. FOR AVENTIS PHARMACEUTICAL·Product code FMF·November 17, 2003

ESSURE

FDA Adverse Event
Injury ·BAYER·Product code HHS·March 2, 2015

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 30, 2011

Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414

FDA Enforcement
Class II ·Ongoing·Stryker Orthopaedics·June 5, 2024

HANDPIECE MICS

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 11, 2017

3.0 RIO® ROBOTIC ARM - MICS

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 18, 2017

NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN·Product code FTR·February 26, 2019

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 5, 2019

VENA SEAL CLOSURE SYSTEM

FDA Adverse Event
Injury ·SAPHEON/MEDTRONIC·Product code MGO·March 3, 2016

BAB CLEAR WATER BLOCK PLUS 30S

FDA Adverse Event
Injury ·SHANGHAI JOHNSON & JOHNSON LTD.·Product code MGO·January 19, 2016

BAND-AID HYDROCOLLOID

FDA Adverse Event
Injury ·COLOPLAST AS·Product code MGO·May 4, 2016

UNKNOWN_KNEE

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·January 26, 2024

REPOSE® TONGUE AND HYOID SUSPENSION KIT

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code LRK·November 14, 2014

UNKNOWN IMPLANTABLE PUMP

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 17, 2013