29 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Intai Anatomic Locking Plate and Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750007431·2630 SERIES SUB-ASSY/ LESS MPC
FAC-4 - Duke Power Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015293·FAC-4 - Duke Power Cabinet
36M - Navajo Tribal Utility Authority
FDA UDI
Certified Safety Manufacturing, Inc.·00766588012797·36M - Navajo Tribal Utility Authority
NAVIGATED INSTRUMENTS;PHOENIX SFS
FDA UDI
Orthofix US LLC·18257200119714·MULTIAXIAL SCREW DRIVER, PHOENIX NAVIGATED BL
BECKER GRATER FLAT
FDA UDI
The Wells Johnson Company·B458201229000·Cannula, Becker Grater Flat, specify length, di...
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER
FDA 510(k)
FDA Class 2
·Orthopedic
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
FDA 510(k)
FDA Class 2
·Immunology
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·July 2, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 27, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 28, 2022
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·August 27, 2012
DIALYSIS UNKNOWN
FDA Adverse Event
Injury
·COVIDIEN MFG SOLUTIONS S.A.·Product code FJS·April 22, 2019
CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 20, 2008
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 29, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 2, 2013
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 11, 2017
UNK BACTISEAL PERITONEAL CATHETER
FDA Adverse Event
Injury
·Product code JXG·December 8, 2017
OMNITRACT
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code GAD·November 12, 2018
NAVISTAR® THERMOCOOL®
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·April 21, 2015