14 results · 21ms · Sources: EU EUDAMED, US FDA

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BIO-LOGIC INSERT EARPHONES

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

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

UNKNOWN ORTHOSIS

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code MNI·January 6, 2017

ASR ACETABULAR IMPLANT 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 2, 2013

LEAD MODEL 304

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·March 23, 2011

22FR MAGNA-PORT GASTROSTOMY TUBE

FDA Adverse Event
Malfunction ·ROSS PRODUCTS DIVISION·Product code KNT·April 18, 2008

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

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

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018