10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERNOMEGA COMPOMER CEMENT
FDA 510(k)
FDA Class 2
·Dental
MODIFIED BETA QUIK STAT EIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Wilson-Cook Achalasia Balloon
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MX40 1.4 GHZ SMART HOPPING
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSI·June 13, 2014
MICRO OSCILLATING SAW
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·February 28, 2013
CHOICE GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·February 9, 2011
WILSON-COOK ACHALASIA BALLOON
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code PID·June 17, 2021
WILSON-COOK ACHALASIA BALLOON
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code PID·October 6, 2020
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·April 17, 2018
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