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