11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SmartLite Pro Modular LED Curing Light
FDA 510(k)
FDA Class 2
·Dental
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074465517·CDH HA COATED MAS 8.5X65
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180543696·65mm Cervical Tooth Blade, Wide
SPORT-ELEC BODY CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
FDA 510(k)
FDA Class 2
·Radiology
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·January 17, 2019
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·February 13, 2019
MICROSTAAR FOAM TIP PLUNGER
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code MSS·October 1, 2008
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 29, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 26, 2013
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024