11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAMBRO POSICLEAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BNF
FDA 510(k)
FDA Class 2
·Orthopedic
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
FDA 510(k)
FDA Class 2
·Orthopedic
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
ENDOTAK DSP
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVY·April 16, 2013
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FDI·June 12, 2008
CLASSIC ADULT COILED PD CATHETER
FDA Adverse Event
Malfunction
·MEDIGROUP, INC·Product code FJS·April 13, 2011
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