MBL

COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS

Advisory panel: Orthopedic
Total cleared: 13

Adverse events under product code MBL

product code MBL

Injury: 439
Total: 439

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MBL

K201157 — Prime BIOFOAM® Multi-Hole Shells Microport Orthopedics, Inc. · 2021-08-24
K201701 — R3 HA Coated Acetabular Shells Smith & Nephew, Inc. · 2020-10-06
K182535 — R3 Anteverted Liners Smith & Nephew, Inc. · 2018-11-19
K161233 — OXINIUM DH Fermoral Heads Smith & Nephew, Inc. · 2016-12-14
K122382 — DYNASTY BIOFOAM SHELL Wrightmedicaltechnologyinc · 2012-10-22
K113848 — R3 XLPE LINERS Smith & Nephew, Inc. · 2012-04-27
K102370 — R3 XLPE ANTEVERTED LINERS Smith & Nephew, Inc. · 2011-01-19
K093363 — COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS Smith & Nephew, Inc. · 2010-01-26
K092386 — R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS Smith & Nephew, Inc. · 2009-11-03
K070756 — SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM Smith & Nephew, Inc. · 2007-06-06
K061253 — REFLECTION 3 ACETABULAR SYSTEM Smith & Nephew, Inc. · 2006-05-31
K960094 — REFLECTION DUAL DIMENSION SHELL Smith & Nephew Richards, Inc. · 1996-03-27
K931107 — LOGYK ACETABULAR COMPONENT SYSTEM Arthronics, Inc. · 1994-03-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.