21 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LONG LIFE PADTM
FDA 510(k)
FDA Class 2
·Neurology
Unity Total Knee System
FDA UDI
CORIN LTD·05056139244049·UNITY KNEE™ PS-C INSERT - Size 5 x 16mm
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000889449·SCREW 3120516 4.0 X 16 SELF DRILL VAR
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994241153·SCREW 3120516 4.0 X 16 SELF DRILL VAR
SMARTLOCK
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540491862·LOCKING SCREW, CROSS-PIN
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113324·PS Insert, Size 5 x 16mm
LEONE SPA
FDA UDI
LEONE SPA·08033707009535·CALIBRA 1ST MOLAR BANDS n.UR 16
BD LUER-LOK TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 3, 2019
CARE IFC PLUS
FDA 510(k)
FDA Class 2
·Neurology
ANYPLUS PEEK CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
MEDTRONIC SCREW 3120516
FDA Adverse Event
Injury
·MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)·Product code KWQ·October 16, 2023
MEDTRONIC PLATE 7200060
FDA Adverse Event
Injury
·MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)·Product code KWQ·October 16, 2023
MEDTRONIC SCREW 3120415
FDA Adverse Event
Injury
·MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)·Product code KWQ·October 16, 2023
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·September 26, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·May 9, 2013
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023