14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Crownjun Nylon Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304512085·
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868273896·
Echo® Press-Fit Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260810·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198727·AK3 Ultra Insert Trial Size 4, 20mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694009720·2.4mm x 20mm Cannulated Lag Screw
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973108146·TRIAL 90-SRK-192420 POLY-MPCS 4X20 LEFT
OsteoMed
FDA UDI
OSTEOMED LLC·00845694070720·Cannulated 2.4 x 20mm Lag Screw Sterile Qty 5
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
FDA 510(k)
FDA Class 2
·Cardiovascular
KRD1 PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PUREFLOW SL
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KPO·October 7, 2008
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 18, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·August 5, 2011
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·July 13, 2016