22 results
·
20ms
·
Sources: EU EUDAMED, US FDA
BERNOULLI VENTILATOR MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304080939·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304080946·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304080915·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304080892·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304080922·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304080885·
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
FDA 510(k)
FDA Class 1
·General Hospital
CM DRIVE IMPLANT 4.3X11.5
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·May 17, 2018
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·March 19, 2013
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·March 9, 2011
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 11, 2008
HIGH CAPACITY NARROW INTRAMEDULLARY TIP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FQH·September 25, 2023
HIGH CAPACITY NARROW INTRAMEDULLARY TIP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FQH·September 25, 2023
UNKOWN BF GLENOIOD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·April 25, 2022
UNKNOWN BF HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 25, 2022
HIGH CAPACITY NARROW INTRAMEDULLARY TIP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FQH·September 25, 2023
HIGH CAPACITY NARROW INTRAMEDULLARY TIP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FQH·September 25, 2023
ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 14, 2017