14 results · 22ms · Sources: EU EUDAMED, US FDA

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UNIVATION

FDA 510(k)
FDA Class 2 ·Orthopedic

XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT

FDA 510(k)
FDA Class 2 ·Radiology

HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX

FDA 510(k)
FDA Class 2 ·Cardiovascular

PINNACLE MTL INS NEUT36IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·March 7, 2013

ARTICULEZE M HEAD 36MM +1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 7, 2013

AMISTEM H FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 22, 2025

IBGSTAR

FDA Adverse Event
Injury ·SANOFI AVENTIS U.S.·Product code NBW·May 22, 2013

SCREW-IN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

BIOMET

FDA Adverse Event
Injury ·BIOMET·Product code JDI·August 20, 2008

VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX

FDA Enforcement
Class II ·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021

Sterile Epidural Tray Catalog Number: 6259R2

FDA Enforcement
Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

MOZEC¿ RX PTCA BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022

MOZEC¿ RX PTCA BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026