15 results
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18ms
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Sources: EU EUDAMED, US FDA
SMARTKNIFE SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
Legacy™ Overdenture Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307111597·
Legacy™ Multi-Unit Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307126751·
Legacy™ Angled Overdenture Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307110859·
simplyFixed Legacy™ Angled
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307117742·
Legacy™ Angled Multi-Unit Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307126614·
simplyFixed Legacy™ Angled
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307117735·
Legacy™ Angled Overdenture Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307110866·
Legacy™ Angled Multi-Unit Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307126621·
PRO-FLOW MULTIPURPOSE CANNULA
FDA 510(k)
FDA Class 2
·Anesthesiology
PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
ENSPIRE FLEX MIS SURGICAL DISCECTOMY SYSTEM
FDA Adverse Event
Injury
·SPINE VIEW INC.·Product code HRX·August 15, 2012
ADEL OBS 6/04
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code HDD·September 21, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022