32 results · 47ms · Sources: EU EUDAMED, US FDA

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ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·October 30, 2018

BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Company·April 1, 2015

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·September 3, 2020

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·October 11, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·May 1, 2019

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·May 25, 2023

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·January 5, 2018

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·November 23, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·October 27, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·August 8, 2018

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·May 11, 2016

Latex-free, Primary I.V. Pump Set with distal microbore patient line and gravity flow prevention valve, convertible pin, 110 inch with secure lock for use with OMNI-FLOW medication management system, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 11606-01.

FDA Recall
Terminated ·Hospira Inc.·Product code FPA·November 24, 2009

LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01

FDA Recall
Terminated ·Hospira Inc.·Product code FPA·December 20, 2006

Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, convertible pin, 110 inch with pre-pierced injection site and OPTION-LOK for use with OMNI-FLOW medication management system, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12160-01.

FDA Recall
Terminated ·Hospira Inc.·Product code FPA·November 24, 2009

Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.

FDA Recall
Terminated ·AlterG, Incorporated·Product code IOL·January 28, 2014

AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product Usage: Rehabilitation of lower body injury & Neurological conditions.

FDA Recall
Terminated ·Alter-G, Incorporated·Product code BXB·July 15, 2011

da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. Intuitive Surgical, Inc. Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

FDA Recall
Terminated ·Intuitive Surgical, Inc.·Product code NAY·February 6, 2012

CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.

FDA Recall
Open, Classified ·B. Braun Medical, Inc.·Product code FPA·September 15, 2022

Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.

FDA Recall
Open, Classified ·B. Braun Medical, Inc.·Product code FPA·September 15, 2022

BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.

FDA Recall
Terminated ·Becton Dickinson & Company·Product code FPA·February 19, 2015