16 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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