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

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Renovis Surgical Hip Replacement System

FDA 510(k)
FDA Class 2 ·Orthopedic

HALO360' COAGULATION CATHETER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NEXSYS PCS SYSTEM

FDA Adverse Event
Malfunction ·HAEMONETICS CORPORATION·Product code GKT·May 12, 2021

REFOBACIN BONE CEMENT R 1X40-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·March 30, 2026

REFOBACIN BONE CEMENT R 1X40-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·February 24, 2026

OPTIPAC 80 REFOB PLUS BONE CMT-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·March 17, 2026

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013

HARMONIC ACE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 18, 2008

REFOBACIN BONE CEMENT R 2X40G

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code MBB·March 12, 2026

REFOBACIN BONE CEMENT R 2X20-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·February 11, 2026

REFOBACIN BONE CEMENT R 2X40G

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·February 20, 2026

OPTIPAC 80 REFOB BONE CMT R-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·November 14, 2025

REFOBACIN BONE CEMENT R 1X40-3

FDA Adverse Event
Death ·BIOMET FRANCE S.A.R.L.·Product code MBB·December 15, 2025

LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DQX·October 8, 2020

REFOBACIN BONE CEMENT R 1X40-3

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBB·December 30, 2024

REFOBACIN BONE CMNT R 1X40 JP

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·May 7, 2025

OPTIPAC 40 REFOB BONE CMT R-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·February 5, 2026

OPTIPAC 60 REFOB BONE CMT R-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·February 5, 2026