20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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