4 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·February 25, 2026
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014