12 results · 20ms · Sources: EU EUDAMED, US FDA

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SHARP CHUTE

FDA 510(k)
FDA Class 2 ·General Hospital

BD SYRINGE LUER-LOK¿ TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 28, 2022

MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY

FDA 510(k)
FDA Class 2 ·Radiology

PROTECTIV SAFETY BLOOD COLLECTION NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

RESOLUTE INTEGRITY RX

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIQ·May 3, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 16, 2014

PUMP IN STYLE BREAST PUMP

FDA Adverse Event
Injury ·MEDELA, INC.·Product code HGX·April 29, 2011

UNKNOWN SALINE IMPLANTS

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·January 28, 2020

UNKNOWN SALINE IMPLANTS

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·January 28, 2020

THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·November 16, 2023

Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.

FDA Enforcement
Class II ·Terminated·Greatbatch Medical·June 8, 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