11 results · 29ms · Sources: EU EUDAMED, US FDA

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OXIMAX NPB-40 HANDHELD PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT

FDA 510(k)
FDA Class 2 ·Immunology

COMPANION SET

FDA Adverse Event
Injury ·ABBOTT NUTRITION·Product code KNT·April 10, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 2, 2014

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·April 4, 2011

ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·April 23, 2025

ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·August 5, 2025

ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·January 16, 2025

Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

FDA Enforcement
Class II ·Terminated·Unomedical As·November 9, 2016

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