18 results
·
29ms
·
Sources: EU EUDAMED, US FDA
StatStrip Xpress Glucose Hospital Meter System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ZenFlex
FDA UDI
Kerr Corporation·00195062030024·Rotary Files
IN-OVATION® R
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189552821·IN-OVATION® R EURO 022 UL/5-5 CS-BC HK
IN-OVATION® R
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189552811·IN-OVATION® R EURO 022 UL/5-5 CS HK
HEMOSIL LA POSITIVE CONTROL
FDA 510(k)
FDA Class 2
·Hematology
U&U STERILE HYPODERMIC NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL 46
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 6, 2020
COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 21, 2024
AL-III W/FOOT CONTROL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEY·October 17, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 21, 2013
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code JOR·July 11, 2011
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·March 14, 2024
COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·March 29, 2024
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·January 10, 2024
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·November 22, 2024
COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·March 28, 2024
COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·December 28, 2023
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023