54 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FISCH TITANIUM MIDDLE EAR PROSTHESES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040120279·Rubber Dam Punch Ainsworth
Alteon
FDA UDI
Exactech, Inc.·10885862608512·
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code LXH·February 10, 2020
BELLEGLASS HP OPAQUE 2
FDA 510(k)
FDA Class 2
·Dental
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·September 27, 2018
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 12, 2018
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·December 13, 2019
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·December 13, 2019
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 21, 2024
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·August 16, 2019
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 11, 2013
ALLURA XPER FD20
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·February 25, 2011
CONTAK RENEWAL 3 RF
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·September 18, 2019
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·March 25, 2019
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·May 9, 2018
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·May 9, 2018
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
FDA Enforcement
Class II
·Terminated·CareFusion 303, Inc.·March 30, 2016