9 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO
FDA 510(k)
FDA Class 2
·Cardiovascular
ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SONOLINE ANTARES ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NV MICROCATHETER
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 9, 2020
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·May 6, 2013
LIGACLIP
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDO·September 12, 2014
SELF CENT HIP 47X28 BRN
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 12, 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