14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HealthCCSng
FDA 510(k)
FDA Class 2
·Radiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704265866·
LCP
FDA UDI
Synthes GmbH·10886982166999·3.5MM LCP® ANTEROLATERAL DISTAL TIBIA PL 5 HOLE...
Broach 44 size 0
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055417·
Coral
FDA UDI
Seaspine Orthopedics Corporation·10889981030292·Screw Offset - Open, 40mm
Sochi
FDA UDI
Altus Spine, LLC·00843210168135·Screw Offset, Open, 40mm
OPUS MAGNUM ANCHOR WITH INSERTER
FDA 510(k)
FDA Class 2
·Orthopedic
DICOMPACS DX-R WITH FLAT PANEL
FDA 510(k)
FDA Class 2
·Radiology
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046736·LATERAL IMPLANT, WIDE, LORDOTIC, 14mm X 23mm X ...
CUP IMPACTOR BOLT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MAY·November 10, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·August 18, 2011
M2A-MAGNUM 42-50MM TAPER INSERT-3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 22, 2013
XP-XP Tibial Tray - Interlok 71 mm Item # 195755
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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