14 results · 24ms · Sources: EU EUDAMED, 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