8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ECHO Photocoagulator
FDA 510(k)
FDA Class 2
·Ophthalmic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112922·CORNEAL TREPHINE BLADE7.75MM
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RF TENT
FDA 510(k)
FDA Class 2
·Radiology
OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE LARGE
FDA Adverse Event
Injury
·BIOMET UK LTD·Product code NRA·August 24, 2011
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·November 3, 2014
GB SCD EXPRESS COMP SYSTEM X1
FDA Adverse Event
Malfunction
·COVIDIEN·Product code JOW·July 2, 2013
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024