19 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERI-PATCH GLUE MOLD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809916491115·Multi-Axial Cannulated Screw, Ø10.5 x 30mm, Ø5....
Arx
FDA UDI
Life Spine, Inc.·00190837188641·
Arx
FDA UDI
Life Spine, Inc.·00190837130596·
Arx
FDA UDI
Life Spine, Inc.·00190837190118·
Arx
FDA UDI
Life Spine, Inc.·00190837130602·
Arx
FDA UDI
Life Spine, Inc.·00190837130619·
Arx
FDA UDI
Life Spine, Inc.·00190837130626·
Arx
FDA UDI
Life Spine, Inc.·00190837175511·
Arx
FDA UDI
Life Spine, Inc.·00190837172572·
NA
FDA UDI
Zimmer, Inc.·00889024274037·
NA
FDA UDI
Zimmer, Inc.·00889024639782·
Coonrad/Morrey Total Elbow
FDA UDI
Zimmer, Inc.·00889024701915·
GEO STRUCTURE
FDA 510(k)
FDA Class 2
·Orthopedic
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL- NEUROMODULATION·Product code GZB·May 6, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·August 20, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021