10 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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BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019
FDA 510(k)
FDA Class 2
·Cardiovascular
MULTI-STIM, MODEL MS-100
FDA 510(k)
FDA Class 2
·Neurology
NORIAN SRS BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·August 4, 2015
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·July 28, 2015
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 3, 2013
THERASPHERE
FDA Adverse Event
Death
·BIOCOMPATIBLES U.K. LIMITED·Product code NAW·August 20, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·May 18, 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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015