10 results
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26ms
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Sources: EU EUDAMED, US FDA
OPEN HEART TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110843·TIP GUARDS VENTED ASSORTED PACK OF 100
OBC BONE ANCHORED HEARING SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
MINIMED QUICK-SET
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·July 14, 2024
UNKNOWN GEL IMPLANTS SMOOTH
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·October 2, 2023
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·December 1, 2010
LRG TAP PRI MOD NCK 16DEG 30MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·January 11, 2013
PRIING SET FOR ARTERIAL BLOODLINES
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code KOC·May 13, 2014
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024