11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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APOLLO GAMMA CAMERA SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111053610·ADULT DUAL STETH 30" PURPLE
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
SUPER 1
FDA 510(k)
FDA Class 2
·Dental
THE INTUITIVE COLORIMETER
FDA 510(k)
FDA Class 1
·Ophthalmic
HELICAL BLADE COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA) BRANDYWINE·Product code LXH·April 16, 2013
WILEY - SPINAL
FDA Adverse Event
Malfunction
·EPIMED INTERNATIONAL, INC.·Product code BSP·June 18, 2008
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 12, 2011
BD INSYTE
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·May 22, 2024
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