7 results
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34ms
·
Sources: EU EUDAMED, US FDA
ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.
FDA 510(k)
FDA Class 2
·Cardiovascular
SETMA HYGIA BATH MODEL ST 7200
FDA 510(k)
FDA Class 2
·Physical Medicine
POST-AURICULAR HEARING AID MODEL PE 600PPCL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LIBERTY CYCLER
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 2, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·December 16, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022