23 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VACUETTE EDTA K2 GEL TUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040008362·Zirlux 16+ A3 89x17x16
ACUFEX
FDA UDI
Smith & Nephew, Inc.·03596010023926·PCH BSKT SCP UPBTR CRVD R 1.3M
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100430·Caddie Lid, Adjustable Cross Links
Ocata Anterior Cervical System
FDA UDI
Kalitec Direct LLC·B07308K0120030·Removal Sleeve
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 11, 2021
ZIP
FDA UDI
AURORA SPINE, INC.·B5211040120430·ZIP 51 MIS Interspinous Fusion System, 12mm x 43mm
TRI-FIT FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
PELVEX HOMETRAINER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 4, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 25, 2013
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 30, 2020
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 7, 2021
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 13, 2021
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 21, 2020
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007
ROD Ø5.5 SOFT CURV L35 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·March 20, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·February 14, 2011
Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
FDA Enforcement
Class II
·Terminated·Integrated Science Systems Inc·June 15, 2016
XIA 3 TITANIUM TORQUE WRENCH
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code NKB·December 27, 2012