10 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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Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MUSTMINI OCCIPITAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025
HIROLLER ELEVATING WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
FDA 510(k)
FDA Class 2
·Orthopedic
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 16, 2008
MUSTMINI OCCIPITAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025
MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKG·April 25, 2024
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022