13 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PULSE CARDULE (MODEL 1859/1860 ECG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Axcent Acrylics
FDA UDI
GARRECO, LLC·D79337601200·Ortho Clear 20lb
VivaDent Polishing Paste
FDA UDI
IVOCLAR VIVADENT AKTIENGESELLSCHAFT·07615208479225·VD Polishing Paste medium Apple 200x1.8g
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110546·QUICK SWITCH IRRIGAT-ASPIRAT HAND PIECE
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471178096·Anatomical Molar Bands, Upper Left 1St & 2Nd Mo...
Inertia® CONNEXX™ Modular Pedicle Screw System
FDA UDI
NEXXT SPINE, LLC·00889929046845·Straight Rod, Ø6.0x120 mm
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
D-SPECT Processing and Reviewing Workstation
FDA 510(k)
FDA Class 2
·Radiology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 18, 2014
FLUOROSCOPIC X-RAY
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 14, 2007
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2010
BMT 360 TIBIAL TRAY 79MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 26, 2020
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025