21 results · 34ms · Sources: EU EUDAMED, 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