14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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