12 results · 21ms · Sources: EU EUDAMED, US FDA

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mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

NuVasive Navigation.S Instruments

FDA 510(k)
FDA Class 2 ·Neurology

MODIFICATION TO VERTE-STACK SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 19, 2014

PROLENE POLYPROPYLENE MESH

FDA Adverse Event
Injury ·ETHICON·Product code FTL·September 22, 2011

SAGITTAL BLADE 18.0X1.27X100MM

FDA Adverse Event
Injury ·STRYKER INSTRUMENTS-KALAMAZOO·Product code GFA·August 2, 2013

Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S

FDA Enforcement
Class II ·Terminated·Brasseler USA, Medical L.L.C.·March 9, 2022

BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).

FDA Enforcement
Class II ·Terminated·Edan Diagnostics·August 17, 2016

BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020