14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
FDA 510(k)
FDA Class 2
·Orthopedic
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304463332·
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260773·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198703·AK3 Ultra Insert Trial Size 4, 16mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694009706·2.4mm x 16mm Cannulated Lag Screw
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973108122·TRIAL 90-SRK-192416 POLY-MPCS 4X16 LEFT
OsteoMed
FDA UDI
OSTEOMED LLC·00845694070683·Cannulated 2.4 x 16mm Lag Screw Sterile Qty 5
POWDERED VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BD GENEOHM VANR ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·October 7, 2008
NANOKNIFE SINGLE ELECTRODE PROBE, 15CM
FDA Adverse Event
Death
·ANGIODYNAMICS·Product code GEI·July 6, 2011
GDC VORTX 2MM X 4MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR CORK·Product code HCG·June 27, 2013
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014