13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PERIMETER INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131256829·NERA PRO, MINIRITE 312 WL DBL
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131669·TiBase HIO 4/6 3.0G NE
THERMODILUTION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
FDA Adverse Event
Malfunction
·LEE LABORATORIES, INC.·Product code MDB·December 12, 2023
RELOAD FOR 60MM ECHELON
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2021
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·October 1, 2014
V-14? CONTROLWIRE®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·May 29, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 16, 2011
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015