8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
FDA 510(k)
FDA Class 2
·Cardiovascular
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110898·TIP GUARDS VENTED YELLOW PACK OF 100
REMSTAR AUTO CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
TRANSRADIAL ARTERY ACCESS DEVICES
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·December 2, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·January 13, 2013
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·July 4, 2018