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

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VITROS XT Chemistry Products ALB-TP Slides

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Bernafon

FDA UDI
Bernafon AG·05711584086032·ZR3 B 105, 2.4G NFM DPB SABE/MSIL ZERENA 3

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690199052·AK3 Congruent Insert Trial Size 3, 16mm

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107705·TRIAL 90-SRK-191316 POLY-MPCS 3X16 RIGHT

LANX SPINAL FIZATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

AAP CANNULATED SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021

STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MCX·June 26, 2013

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·July 27, 2011

CAREASSIST

FDA Adverse Event
Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·September 26, 2008

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025

BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER

FDA Adverse Event
Malfunction ·C.R. BARD INC. (COVINGTON) -1018233·Product code MJC·June 19, 2025

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025

COMP NLK SCR 3.5HEX 4.75X25 XT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·July 23, 2020

COMP LK SCR 3.5HEX 4.75X20 ST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·July 23, 2020

M-VIZION PROXIMAL BODY HANDLE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026