8 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200
FDA 510(k)
FDA Class 2
·Cardiovascular
CIRCUITGUARD CIRCUITGUARD HME
FDA Adverse Event
Other
·ARC MEDICAL INC., ANESTHESIA & RESPIRATORY CARE·Product code BYD·July 20, 2005
Merit Syringe
FDA 510(k)
FDA Class 2
·General Hospital
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013
3.5MM TI CANCELLOUS POLYAXIAL
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNI·February 1, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024