17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JO H20 Water Based Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526814721·GENUMEDI PSS GREEN O
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304002487·
TiLock
FDA UDI
Genesys Orthopedics Systems LLC·M719G1504800·Pre-Bent Rod
SunMed
FDA UDI
SUNMED, LLC·20889483042820·CC GUEDEL A/W SZ 80mm PK/10
PDE PHOTODYNAMIC EYE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
FDA 510(k)
FDA Class 2
·Anesthesiology
X-SUIT NIR COVERED BILIARY METALLIC STENT
FDA Adverse Event
Malfunction
·MEDINOL LTD.·Product code FGE·December 27, 2017
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
GIA 60-3.8 SINGLE USE RELOADABLE STAPLER
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·June 16, 2011
CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MFJ·September 5, 2008
SOLITAIRE REVASCULARIZATION DEVICE
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code NRY·July 25, 2017
EOS PMP, EOS PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2021
DIDECO EOS ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·May 13, 2021
SORIN LIFEKIT D905 EOS ECMO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 14, 2021
EOS PMP, EOS PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·March 23, 2022
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017