9 results · 18ms · 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.

BLACKSTONE SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SYRINGE TIP ADAPTOR

FDA 510(k)
FDA Class 2 ·General Hospital

PRO-LOK (TM) EXTENSION SETS

FDA 510(k)
FDA Class 2 ·General Hospital

MTS ANTI-IGG GEL CARD

FDA Adverse Event
Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·March 8, 2013

MINI-CAP, DISCONNECT W/PVP-1SOLUTION

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·February 17, 2011

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 24, 2014

LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

FDA Recall
Terminated ·Zest Anchors LLC·Product code DZE·January 16, 2014

LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

FDA Enforcement
Class II ·Terminated·Zest Anchors LLC·February 12, 2014

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026