10 results
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18ms
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Sources: EU EUDAMED, US FDA
Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)
FDA 510(k)
FDA Class 2
·Anesthesiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517632166·CoRoent Ant TLIF Ti, 15x13x32mm 12°
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197181785·Dittel Dilating Bougies
Charr....
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197181792·Dittel-Bougies, slightly curved,
35.5 c...
SpyGlass Discover Retrieval Basket
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCOLADE (127 DEG) SIZE 2.5
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS CORK·Product code MEH·August 3, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 29, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 28, 2015
Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.
FDA Enforcement
Class II
·Terminated·Allen Medical Systems, Inc.·March 27, 2013