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

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NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System

FDA 510(k)
FDA Class 2 ·Orthopedic

MAXIM VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304205765·

MAXIM® VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00887868225833·

FUKUDA DENSHI

FDA 510(k)
FDA Class 2 ·Cardiovascular

METRX WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD

FDA Adverse Event
Injury ·Product code LZO·October 10, 2014

EASYSPINE SCREW, UNKOWN SIZE OR TYPE

FDA Adverse Event
Injury ·LDR MEDICAL·Product code NKB·August 17, 2020

ACCU-CHEK ® SOFTCLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·June 28, 2011

NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 7 -

FDA Adverse Event
Injury ·ZIMMER TMT·Product code JWH·May 29, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MPRI·Product code DTB·October 6, 2014

EASY SPINE SCREW, UNKNOWN

FDA Adverse Event
Injury ·LDR MEDICAL·Product code NKB·March 24, 2020

EASY SPINE ROD, UNKNOWN

FDA Adverse Event
Injury ·LDR MEDICAL·Product code NKB·March 24, 2020

EASY SPINE SCREW, UNKNOWN

FDA Adverse Event
Injury ·LDR MEDICAL·Product code NKB·March 24, 2020

EASY SPINE SCREW, UNKNOWN

FDA Adverse Event
Injury ·LDR MEDICAL·Product code NKB·March 24, 2020

EASY SPINE SCREW, UNKNOWN

FDA Adverse Event
Injury ·LDR MEDICAL·Product code NKB·March 24, 2020

EASY SPINE ROD, UNKNOWN

FDA Adverse Event
Malfunction ·LDR MEDICAL·Product code NKB·March 24, 2020

EASYSPINE SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code NKB·July 9, 2019

PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021