11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEINE SIGMA 250 & HEINE SIGMA 250 M2
FDA 510(k)
FDA Class 2
·Ophthalmic
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·March 31, 2016
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
LIQUICHEK ELEVATED CRP CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NEXGEN LCCK ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·May 24, 2013
SIGNA HORIZON CX
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code LNH·September 23, 2014
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 20, 2011
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