17 results · 22ms · Sources: EU EUDAMED, 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