12 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGICAL MESH SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132150·Trial, TLIF, 27L OB CRV 7Deg, 15mm
DASH Apex 4 Centrifuge, Medline
FDA UDI
DRUCKER DIAGNOSTICS·00810052864594·General purpose laboratory centrifuge for sampl...
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
CELL-DYN DILUENT/SHEATH
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 11, 2013
STERRAD 50 STERILIZATION SYSTEM
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·May 28, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011
CELL-DYN RUBY SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code GKZ·November 10, 2023
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
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