28 results · 24ms · Sources: EU EUDAMED, US FDA

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NewPrim System

FDA 510(k)
FDA Class 2 ·Orthopedic

Medline

FDA UDI
MEDLINE INDUSTRIES, INC.·10889942144396·PACK ARTHROGRAM

Oticon

FDA UDI
Oticon A/S·05707131340177·SIYA 2, KIT 312 NFM 85 R C001

PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC

FDA 510(k)
FDA Class 2 ·Ophthalmic

ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040

FDA 510(k)
FDA Class 2 ·Cardiovascular

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 19, 2020

LADARVISION 4000 LASER

FDA Adverse Event
Malfunction ·ALCON-ORLANDO TECHNOLOGY CENTER·Product code LZS·October 1, 2008

CELL-DYN SAPPHIRE ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 4, 2011

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013

LINER: MPACT FLAT PE HC LINER 36/E

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·May 27, 2021

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 20, 2025

BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2023

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 17, 2025

STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 10

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 15, 2021

BD KIESTRA IDENTIFA

FDA Adverse Event
Malfunction ·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025

MPACT 3D METAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·May 29, 2026

CD HORIZON ASTUTE SPINAL SYSTEM

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code NQP·April 16, 2021

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 5, 2026

LINER: MPACT FLAT PE HC LINER Ø36/F

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·July 13, 2023

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 6, 2025