19 results
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38ms
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Sources: EU EUDAMED, US FDA
WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRANSAMERICAN TENS
FDA 510(k)
FDA Class 2
·Neurology
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code FAD·June 8, 2023
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code FAD·June 8, 2023
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code FAD·June 8, 2023
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code FAD·June 8, 2023
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code FAD·June 8, 2023
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code FAD·June 8, 2023
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·October 30, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 14, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018
V40 COCR LFIT HEAD 36MM/+5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·April 22, 2013
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code DHA·April 27, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 27, 2020
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018