16 results · 25ms · Sources: EU EUDAMED, US FDA

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LCP RADIAL HEAD PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MILLENNIUM OXYGEN CONCENTRATOR

FDA Adverse Event
Injury ·RESPIRONICS INC·Product code CAW·February 25, 2016

BD¿ ENTERAL SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·February 13, 2023

SAMPLOK

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX

FDA 510(k)
FDA Class 2 ·Anesthesiology

BIPAP A40

FDA Adverse Event
Malfunction ·RESPIRONICS·Product code MNT·September 13, 2018

SERIES A PAT W/WR THN 28 1 PEG

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·January 12, 2022

MILLENNIUM OXYGEN CONCENTRATOR

FDA Adverse Event
Death ·RESPIRONICS, INC.·Product code CAW·February 28, 2018

EVERFLO OXYGEN CONCENTRATOR

FDA Adverse Event
Malfunction ·RESPIRONICS INC·Product code CAW·June 19, 2015

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·April 8, 2013

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·May 9, 2008

VITALITY 2

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

EVERFLO OXYGEN CONCENTRATOR

FDA Adverse Event
Malfunction ·RESPIRONICS INC·Product code CAW·July 20, 2016

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018