10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
FDA 510(k)
FDA Class 2
·Neurology
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981427047·Working Tube, Light Port, 16 x 50mm
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027575·
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
FDA 510(k)
FDA Class 2
·Immunology
TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
ENDURANT II
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·October 1, 2014
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·May 1, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 17, 2011
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023