11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AESCULAP STERILCONTAINER S
FDA 510(k)
FDA Class 2
·General Hospital
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
EECP THERAPY SYSTEM, MODEL TS3
FDA Adverse Event
Injury
·VASOMEDICAL, INC.·Product code DRN·December 30, 2002
TRITON HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
LINER AND SHELL WITH PLASTIC BARRIER 48 MM I.D. 60 MM O.D.
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 3, 2023
ADAPTER SLEEVES 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 6, 2013
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·April 6, 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