12 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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Ogmend® Implant Enhancement System
FDA 510(k)
FDA Class 2
·Orthopedic
REAMER HEAD 7.5mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000597·
TriVerse Modular Tray Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215097684·
BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E
FDA 510(k)
FDA Class 2
·Physical Medicine
TIBIAL/PELVIC TRACKER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·November 4, 2014
HILL ROM CENTRA 852 SERIES HOSPITAL BED
FDA Adverse Event
Malfunction
·HILL ROM·Product code FNL·August 19, 2011
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025