11 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115
FDA 510(k)
FDA Class 2
·Radiology
Aligned Medical Solutions
FDA UDI
Aligned Medical Solutions·B09800624720·Small Basin Kit
DELTA 32 AND DELTA 32 TACT
FDA 510(k)
FDA Class 2
·Radiology
A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
STONEBREAKER SINGLE USE PROBE
FDA Adverse Event
Malfunction
·COOK INC·Product code FFK·March 28, 2018
5.0MM FLEXIBLE SHAFT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·April 16, 2013
SUPERLINE
FDA Adverse Event
Injury
·DENTIUM USA·Product code DZE·April 6, 2011
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·June 18, 2008
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
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015