58 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131261106·H10, MINIRITE 312 WL TC
DreamWear Full
FDA UDI
Respironics, Inc.·00606959046085·DreamWear Full Mask, Medium, with Small Frame, ...
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
NXSTAGE PUREFLOW SOLUTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DUO FLUID CART
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·December 21, 2017
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·August 31, 2018
BD VACUTAINER® SINGLE USE HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·December 6, 2017
ACX DOUBLE CHAMBER TISSUE EXPANDER
FDA Adverse Event
Injury
·SIENTRA, INC·Product code LCJ·May 24, 2013
PINN LNR +4 10D 28IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWZ·June 13, 2011
ROTICULATOR 30-V3 TITANIUM STAPLER
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·August 22, 2008
ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·June 25, 2020
PERIPHERAL NERVE BLOCK SUPPORT TRAY
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code CAZ·October 1, 2014
EVAC STATION
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·September 5, 2017
CONTINUOUS TRAY WITH 100MM NEEDLE, STIMULATING
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code CAZ·October 2, 2014
ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·January 11, 2018
EVAC STATION
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·January 16, 2018
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·June 7, 2018
Philips Respironics DreamWear Full Face Mask
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·October 12, 2022
CONTINUOUS TRAY WITH 100MM NEEDLE 4IN ECHO NEE
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code CAZ·October 3, 2014