11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GC Initial™
FDA UDI
Gc America Inc.·J0228700461·GC Initial™ MC Opaqus Dentin ODD4, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556702137·GC Initial™ MC Opaqus Dentin ODD4, 20g
Arthrex®
FDA UDI
ARTHREX, INC.·00888867317956·Lobster Clamp, Mini
Lilium a-200E
FDA 510(k)
FDA Class 2
·Radiology
POWDERED VINYL PATIENT GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 12, 2014
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·October 15, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·December 12, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024