17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O
FDA 510(k)
FDA Class 1
·General Hospital
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 18, 2021
KADANCE 2000
FDA 510(k)
FDA Class 2
·Orthopedic
SIMPLICITY SOFT INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 26, 2021
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 26, 2021
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 26, 2021
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 29, 2025
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 29, 2025
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 18, 2021
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 18, 2021
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 18, 2021
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 3, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 8, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·May 2, 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