18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cerament Bone Void Filler
FDA 510(k)
FDA Class 2
·Orthopedic
EarQ
FDA UDI
Oticon A/S·05707131350374·G50 S, BTE PP 13 2.4G 105 C090 EARQ
SUTURE RING WITH TABS
FDA UDI
KATENA PRODUCTS, INC.·00841668111727·
18M - Loggers - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015057·18M - Loggers - 18 Metal
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512206·"An absorbent paper points is an endodontic pap...
APPLE ECG (ELECTROCARDIOGRAPH) APP
FDA Adverse Event
Injury
·APPLE INC.·Product code QDA·July 5, 2023
SurgyCut
FDA UDI
U.S. SURGITECH INC.·00810014631851·SurgyCut Fully Disposable Scissor, 5mm/35cm
SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·February 6, 2025
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
FDA 510(k)
FDA Class 2
·Orthopedic
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Meduloc Intramedullary Fracture Fixation (IFF) System
FDA UDI
MEDULOC, LLC·00810184540397·Sterile Meduloc IFF System Implant Kit (3.5L)
MICRO 20G
FDA UDI
The Wells Johnson Company·B458201535000·Cannula, Micro 20g, on dll, specify length and ...
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·October 17, 2008
PERCUTANEOUS TRIAL LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 4, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 30, 2025
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018