21 results
·
28ms
·
Sources: EU EUDAMED, US FDA
WAMPOLE HS-CRP ELISA
FDA 510(k)
FDA Class 2
·Immunology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810118551·Maxima Gutta Percha Points CC
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040140816·Maxima Gutta Percha Points CC
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040099919·Maxima Gutta Percha Points CC
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012666·Zirlux 16+ B4 95X25
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361011125·PedFuse RespondX, CNL, 6.0mm x 55mm
RANDOX IGE
FDA 510(k)
FDA Class 2
·Immunology
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCREW LOCKING
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·March 14, 2012
SCREW
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·March 14, 2012
SCREW
FDA Adverse Event
Injury
·SYNTHES OBERDORF·Product code HWC·March 14, 2012
SCREW
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·March 14, 2012
SCREW
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·March 14, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 19, 2013
MINI-CAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 9, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 11, 2008
11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·February 11, 2016
3.5MM TI LCP® PROXIMAL HUMERU PLATE-STANDARD 3H SHAFT/90MM
FDA Adverse Event
Injury
·SYNTHES RARON·Product code KTW·February 16, 2016
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injection site to provide a pathway for IV fluid administration.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·January 22, 2014
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015