8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
FDA 510(k)
FDA Class 1
·Ophthalmic
VIDAS TESTOSTERONE (TES), MODEL 30 418
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 10, 2013
4.0MM TOMCAT CUTTER, FORMULA (5BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code HRX·May 22, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
AV FISTULA , Model No UTAV77T
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025
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