10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VARISOURCE 200 HDR AFTERLOADER
FDA 510(k)
FDA Class 2
·Radiology
REMEL
FDA UDI
REMEL, INC.·00848838008337·Nutrient Broth (5ml) 20/PK
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
FDA 510(k)
FDA Class 2
·Radiology
QCU ANALYTICAL SOFTWARE PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 21, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 16, 2013
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 18, 2011
CAPSURE EPI
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·June 12, 2008
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