11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
FDA 510(k)
FDA Class 2
·Cardiovascular
NC TREK OTW CORONARY DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 31, 2012
1.5X6MM HT SD X-DR SCR
FDA Adverse Event
BIOMET MICROFIXATION·Product code HWC·August 24, 2010
11MM/130 DEG TI CANN TFNA 420MM/RIGHT - STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·October 11, 2018
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023