17 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ULTRA ZYME PLUS AMYL 64982, GILFORD 3500
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Archon
FDA UDI
Nuvasive, Inc.·00887517204332·Archon Screw, 4.5x13mm Self-Tap Fixed
LEONE SPA
FDA UDI
LEONE SPA·08033707067511·LIGATING MODULES 1,3mm TRANSPARENT
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77805131·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
LEONE SPA
FDA UDI
LEONE SPA·08033707067597·LIGATING MODULES 1,3mm GREY
MicroFrance®
FDA UDI
INTEGRA MICROFRANCE·10381780089476·MicroFrance® Seemann-Seiffert mouth-gag, 110 mm
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77805130101·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77805131001·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77805130051·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
QLASER SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
CustomizedBone Service
FDA 510(k)
FDA Class 2
·Neurology
ARTICULEZE M HEAD 36MM +5 K980513
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 14, 2016
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 10, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 16, 2007
NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024