39 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MIGRA TAB, QUICKSPLINT MIGRAINE
FDA 510(k)
FDA Unclassified
·Unknown
Depth gauge
FDA UDI
Jeil Medical Corporation·08809282815621·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213015494·microSelectron Transfer Tube for 5F Flexibles (14)
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390864039·
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AQUILION PRIME
FDA 510(k)
FDA Class 2
·Radiology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523103744·Hemispherical Shell, No Hole, 66mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166367·Initia T3 Acetabular Hemispherical Shell, No Ho...
BIZACT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·June 18, 2019
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024130135·
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024130128·
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024130159·
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024130142·
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 19, 2020
SYSTEM 2000
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code ILJ·April 19, 2013
SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·May 23, 2011
PROXIMATE PPH PROCEDURE SET
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 13, 2008
BIZACT
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·April 30, 2024
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 8, 2018
Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·October 24, 2012