11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
FDA 510(k)
FDA Class 1
·General Hospital
SeaSpine Spacer System - Redondo™
FDA UDI
Seaspine Orthopedics Corporation·10889981045487·Redondo Trial 34mm x 24mm x 16mm, 8 Deg
VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BATTERY PACK #1012NC
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 30, 2013
ESPRIT
FDA Adverse Event
Injury
·SORIN BIOMEDICA C.R.M., S.R.L.·Product code NVZ·December 15, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 15, 2014
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 28, 2020
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 29, 2020
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 28, 2020
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