Devices

Name Classification Manufacturer Risk Class Country Source
Endopath ETS Compact Flex 45mm Articulating Linear Cutter Johnson & Johnson Malaysia
ETHILON. Suture, ETHIBOND. and MERSILENE. Polyester Fiber SUTURES and MERSILK. SUTURES, MULTIPLE LOTS Johnson & Johnson Malaysia
Sterrad Sterilisers Johnson & Johnson Malaysia
STERRAD 50 Sterilizer Johnson & Johnson Malaysia
CORDIS Cypher Select + Sirolimus-eluting Coronary Stent Johnson & Johnson Malaysia
KYPHX HV-R BONE CEMENT Medtronic Malaysia
CoreValve Delivery System (DCS) Model:- DCS-C3-18FR or DCS-C4-18FR1 Medtronic Malaysia
SynchroMed II infusion pumps Medtronic Malaysia
Maximo II ICD, DR ICD and CRT-D Medtronic Malaysia
Prostiva RF Model 8929 Hand Piece Device Medtronic Malaysia
MEDTRONICS Dual Chambers Pacemaker Medtronic Malaysia
LIFEPAK 15 Monitor/Defibrillator Medtronic Malaysia
MODEL 5388 DUAL CHAMBER EXTERNAL TEMPORARY PULSE GENERATOR Medtronic Malaysia
CONSULTA CRT-D, SECURA DR/VR, CONCERTO II CRT-D, VIRTUOSO II DR/VR, MAXIMO II CRT-D, MAXIMO I Medtronic Malaysia
Deep Brain Stimulation Lead Kits Model 3387, 3387S, 3389 and 3389S Medtronic Malaysia
LIFEPAK 20 AND LIFEPAK 20e DEFIBRILLATORS/MONITORS Cardiovascular Devices Medtronic Malaysia
EnRhythm Pacemakers Medtronic Malaysia
Gambro and Hospal blood sets (lot numbers 0806 –0817) Gambro Renal Products Malaysia
THERMO SCIENTIFIC HM355S-31 Microm International GmbH Malaysia
Procedure packs from various manufacturers which contain BD Medical Surgical Syatems 2ml, 5ml, and 10ml Plastipak Luer Slip syringes BD Malaysia
Thoratec Heartmate II Left Ventricular Assist System (HM II LVAS) System Controllers Thoratec Corporation Malaysia
Polydent Denture Adhesive Cream GlaxoSmithKline Malaysia
SleepStyle Series CPAP – Power Cord Fisher & Paykel Healthcare Malaysia
Clear & Simple Digital Pregnancy Test Guangzhou Wondfo Biotech Co. Ltd. Malaysia
Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System Cardiovascular Devices Arrow International Inc Malaysia