11 results
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26ms
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Sources: EU EUDAMED, US FDA
MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NA
FDA UDI
STERIS CORPORATION·10724995152502·The Vis-U-All High Temperature Self Seal Steril...
INFANT VENT CATHETER 12001 W/SIDE VENT
FDA 510(k)
FDA Class 2
·Cardiovascular
AZTECH INDUSTRIES SUNTANNING BED AZ100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 9, 2014
SHILEY FENESTRATED LOW PRESSURE CUFFED
FDA Adverse Event
Injury
·COVIDIEN / FORMERLY TYCO HEALTHCARE·Product code JOH·October 13, 2010
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Death
·RICE CREEK MFG·Product code DTB·December 21, 2012
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
FDA Recall
Terminated
·Steris Corporation·Product code FRG·December 2, 2020
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Enforcement
Class II
·Terminated·Steris Corporation·March 7, 2018
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024