24 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
FDA Enforcement
Class II
·Terminated·OMNIlife science Inc.·September 11, 2019
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
FDA Enforcement
Class II
·Terminated·OMNIlife science Inc.·September 11, 2019
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
FDA Enforcement
Class II
·Terminated·OMNIlife science Inc.·September 11, 2019
Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
FDA Enforcement
Class II
·Terminated·OmniLife Science·November 24, 2021
OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System.
FDA Enforcement
Class II
·Terminated·OMNIlife science Inc.·June 12, 2019
OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
FDA Enforcement
Class II
·Terminated·OMNIlife science Inc.·October 30, 2019
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
FDA Enforcement
Class II
·Terminated·Omnilife Science Inc.·August 27, 2014
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
FDA Enforcement
Class II
·Terminated·OMNIlife science Inc.·February 3, 2021
SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
FDA Enforcement
Class II
·Terminated·OMNIlife science Inc.·February 3, 2021
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128
FDA Enforcement
Class II
·Terminated·OMNIlife science Inc.·February 3, 2021
Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
FDA Enforcement
Class II
·Terminated·Omnilife Science Inc.·September 2, 2015
Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
FDA Enforcement
Class II
·Terminated·Omnilife Science Inc.·September 2, 2015
OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty
FDA Enforcement
Class III
·Terminated·OMNI LIFE SCIENCE·November 23, 2016
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
FDA Enforcement
Class II
·Terminated·Omnilife Science Inc.·September 2, 2015