21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Juliet® Ti
FDA 510(k)
FDA Class 2
·Orthopedic
Bard® Extension Cord
FDA UDI
C. R. Bard, Inc.·00801741045868·Bard® Extension Cord
Zavation
FDA UDI
Zavation LLC·00842166180659·ALIF Sizer 15deg 36mm x 21mm
ZAVATION
FDA UDI
Zavation LLC·00842166154988·WHITNEY 15deg 36mmx21mm
Zavation
FDA UDI
Zavation LLC·00842166106277·ALIF 15deg 36mmx21
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575183555·Proximal tibial spacer, uncemented, Ti6Al4V, fo...
ZAVATION
FDA UDI
Zavation LLC·00842166157200·HA+ ALIF 15deg 36mmx21
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575183470·Proximal tibial spacer, uncemented, Ti6Al4V, fo...
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575268627·Proximal tibial spacer, uncemented, Ti6Al4V, fo...
OPTICROSS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 22, 2025
OPTICROSS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 23, 2025
SMARTDRIVE WHEELCHAIR POWER-ASSIST
FDA 510(k)
FDA Class 2
·Physical Medicine
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CODA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·January 30, 2019
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 30, 2019
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 7, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014