19 results · 38ms · Sources: EU EUDAMED, US FDA

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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