5 results · 7ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.

FDA Enforcement
Class II ·Terminated·Synvasive Technology Inc·April 24, 2013

Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip

FDA Enforcement
Class II ·Terminated·Exactech, Inc.·July 5, 2017

LoFric Origo, Nelaton, 16in, FR10 urinary catheters

FDA Enforcement
Class II ·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020

LoFric Origo, Tiemann, 16in, FR12 urinary catheters

FDA Enforcement
Class II ·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020

LoFric Origo, Tiemann, 16in, FR14 urinary catheters

FDA Enforcement
Class II ·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020