10 results · 28ms · Sources: EU EUDAMED, US FDA

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ISITE PACS, V 4. X

FDA 510(k)
FDA Class 2 ·Radiology

POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS

FDA 510(k)
FDA Class 1 ·General Hospital

SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A

FDA 510(k)
FDA Class 2 ·Hematology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

ISA CO2

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022

AC POWER MODULE

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 26, 2013

PROLENE POLYPROPYLENE SUTURE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code GAW·April 19, 2011

PFCSIG FLUT FEMROD 5DG14X175MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC., DEPUY-RAYNHAM·Product code JWH·June 18, 2008

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·December 2, 2022

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