24 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRAFTON PLUS DBM PASTE
FDA 510(k)
FDA Class 2
·Dental
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809867985·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...
PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
ESTENIA
FDA 510(k)
FDA Class 2
·Dental
10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING
FDA Adverse Event
Injury
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·May 1, 2023
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75 X 14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75X14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
STANDARD CRANITOME, BLACK MAX
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code GFF·April 2, 2013
SENSIA SR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·April 6, 2011
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67X14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
VANGUARD DA 360 TIBIAL BEARING ARCM 71/75X16
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 28, 2017
VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·February 6, 2017
VG DA360 TIB BRG ARCM 79/83X14 3 X 14MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·October 31, 2017
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 2, 2017
VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 13, 2016
VANGUARD DA 360 TIBIAL TRAY
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 27, 2017
VANGUARD SSKPSC TIBIAL BEARING S 12X63/67
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 21, 2017
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
CERELINK ICP EXT CABLE
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES MANSFIELD·Product code GWM·August 2, 2022