14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLM SENSOR, MODEL PLM1
FDA 510(k)
FDA Class 2
·Anesthesiology
KENAFLEXX
FDA UDI
KENTRON HEALTHCARE, INC.·00810003750099·12" IV EXTENSION SET WITH FEMALE LUER, KENTRON ...
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591011185·Tri-Panel Knee Immobilizer, 14"
VARIAX
FDA UDI
Stryker GmbH·04546540704122·Reduction Inst. Insert
SIGMA
FDA UDI
DEPUY (IRELAND)·10603295223405·SIGMA FEMORAL CRUCIATE RETAINING POROCOAT SIZE ...
Glide
FDA UDI
INFINITE BIOMEDICAL TECHNOLOGIES, LLC·00850004850879·Glide Fabrication kit with 4 dummies
CHEMODENT CERAMIC METAL
FDA 510(k)
FDA Class 2
·Dental
PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
FDA 510(k)
FDA Class 2
·Anesthesiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·February 1, 2013
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·December 28, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2014
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·January 24, 2023
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·January 24, 2023
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020