8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WARD-CSS (v1.2.x)
FDA 510(k)
FDA Class 2
·Cardiovascular
ERB ENDORECTAL BALLOON
FDA 510(k)
FDA Class 2
·Radiology
ETD Family of Electrotherapy Devices
FDA 510(k)
FDA Class 2
·Physical Medicine
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
OSCILL-SAW-ATTACHM W/QUICK-COUPL F/COMPA
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GFA·November 10, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 2, 2015
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter transition from the dilator. The dilator components utilize tip indicator bands for minimum tip alignment of the component parts. The cannula body is marked for depth insertion. The components are designed to fit over each other to progressively dilate the vessel during insertion. The dilator allows a 0.1-cm (0.038-in) guidewire to pass through it to aid in insertion. A soft, tapered transition fitting terminates in a 0.95-cm (3/8-in) connection site or barbed connector.
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DWF·June 12, 2015