15 results · 18ms · Sources: EU EUDAMED, US FDA

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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