14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Quanta Forte
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Persona Total Knee System
FDA UDI
Zimmer, Inc.·00889024489189·
Persona Total Knee System
FDA UDI
Zimmer, Inc.·00889024489202·
Persona Total Knee System
FDA UDI
Zimmer, Inc.·00889024489172·
Persona Total Knee System
FDA UDI
Zimmer, Inc.·00889024489196·
RAVE COMPOSITE BRACKET
FDA 510(k)
FDA Class 2
·Dental
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 29, 2019
CAPSURE Z NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 7, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 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
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