14 results · 21ms · 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.

AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690190646·Femoral Sizing Guide Bushing 3 deg +2mm

MEDISYSTEMS PHERESIS NEEDLE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay

FDA 510(k)
FDA Class 2 ·Radiology

MERSILENE POLYESTER FIBER MESH

FDA Adverse Event
Injury ·JOHNSON & JOHNSON INTERNATIONAL·Product code FTL·July 27, 2017

SS-IMPL, PLUS, Ø 4.1MM, L 12.0MM

FDA Adverse Event
Injury ·INSTITUT STRAUMANN AG·Product code DZE·June 7, 2022

TAXUS® LIBERTÉ®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 14, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 28, 2014

HOMECHOICE CYCLER-REFURBISHED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 17, 2011

SET SCREW, 8 MM, 21 MM, HEX 3.5 MM

FDA Adverse Event
Malfunction ·ZIMMER GMBH·Product code HSB·April 23, 2019

LOGIC FEMORAL PS CEM RIGHT SZ 5

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·November 20, 2024

ZNN, CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW

FDA Adverse Event
Malfunction ·ZIMMER GMBH·Product code HSB·April 23, 2019

Z NAIL CPM 13MMX21.5CM 125 R

FDA Adverse Event
Malfunction ·ZIMMER GMBH·Product code HSB·April 23, 2019

Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024