16 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ER-REBOA Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304674448·
ATTUNE AOX AFFIXIUM
FDA UDI
DEPUY (IRELAND)·10603295523611·ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALI...
ATTUNE AOX AFFIXIUM
FDA UDI
DEPUY (IRELAND)·10603295523628·ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALI...
ATTUNE AOX AFFIXIUM
FDA UDI
DEPUY (IRELAND)·10603295523604·ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALI...
ATTUNE AOX AFFIXIUM
FDA UDI
DEPUY (IRELAND)·10603295523635·ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALI...
BIOPSY VALVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENSPIRE FLEX
FDA Adverse Event
SPINE VIEW, INC.·Product code HRX·June 3, 2013
ACCESS
FDA Adverse Event
Malfunction
·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·March 1, 2016
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·March 1, 2016
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023