Andreas Hettich GmbH & Co KG
Centrifuges. Rotofix 32 A; 1206 / 1206. FSN 01 December 2011 (242Kb).
MHRA ref: 2013/002/012/081/003
Staples and staple guns; endoscopic linear stapler/cutter. Endo GIA Auto Suture SULU 30mm-2.0mm. FSN February 2013 (108Kb).
MHRA ref: 2013/002/011/291/011
Radiotherapy; linac. XVI – R3.5, R3.5.1 R4.0, R4.2, R4.2.1, R4.5, R4.5.1, R4.6. FSN January 2013(258Kb).
MHRA ref: 2013/002/005/291/011
GE Medical Systems SCS
X-ray, fluoroscopy systems fluoroscopy system. 2236709, 2353620, 2223039-2, 2270677-2 – CRT monitor suspension manufactured by GEHC. FSN 13 February 2013 (114Kb).
MHRA ref: 2013/002/013/291/017
Implant materials, bone substitute. Eurospine – HRCCS4S. FSN 21 January 2013 (201Kb)
MHRA ref: 2013/001/031/291/022
Implantable ventricular assist devices; ventricular – pump. HVAD system – 1100, 1102, 1104, 1205. FSN February 2013 (148Kb).
MHRA ref: 2013/002/008/291/009
Infusion systems, electrically powered infusion pump. Plum A+. FSN 25 January 2013 (991Kb).
MHRA ref: 2013/001/022/081/010
Infusion systems, electrically powered infusion pump. Plum A+. FSN 14 February 2013 (61Kb).
MHRA ref: 2013/001/024/081/012
Impac Medical Systems Inc
Radiotherapy, planning and verification systems software. Monaco RTP System. undated FSN (110Kb).
MHRA ref: 2013/002/011/081/019
Joerns Healthcare Ltd
Hoists, moving and handling, frame. Advance. FSN 11 February 2013 (350Kb).
MHRA ref: 2012/011/007/081/020
Johnson & Johnson International / Ethicon
Suture, absorbable. Vicryl™ polyglactin 910 suture. FSN February 2013 (197Kb).
MHRA ref: 2013/002/014/601/001
Joint prosthesis, hip. Spacers for Delta liners in Delta acetabular system; product codes: 5885.15.5XX, 5886.15.5XX. FSN 06 February 2013 (207Kb)
MHRA ref: 2013/002/011/291/001
Implants, active, leads, neuro; neurostimulation electrodes. Deep brain stimulation (DBS) lead kits. FSN February 2013 (188Kb).
MHRA ref: 2013/002/008/081/018
Newdeal / Integra
Surgical instruments. Cannulated screwdriver and screwdriver tip. FSN February 2013 (592Kb)
MHRA ref: 2013/002/008/081/013
Nikkiso Europe (distributor: Baxter Healthcare)
Dialysis, haemofilters; haemofiltration machine. Aquarius. FSN February 2013 (898Kb).
MHRA ref: 2008/011/024/291/007
Oraya Therapeutics Inc
Radiotherapy treatment system. Oraya ophthalmic tray assembly. FSN 07 February 2013 (1336Kb).
MHRA ref: 2013/002/008/291/001
Roche Diagnostics GmbH
IVDs, clinical chemistry instrumentation. ALP2, CREJ2, CRPL3, UREAL, ALT, CO2-L for cobas c systems. FSN 21 January 2013 (105Kb). Update to: FSN 24 October 2012 (240Kb).
MHRA ref: 2012/010/031/081/006
Siemens Healthcare Diagnostics Inc
IVDs, clinical chemistry reagent. Dimension® Phosphorus (PHOS) Flex® reagent cartridge. FSN February 2013 (47Kb).
MHRA ref: 2013/002/012/601/013
Siemens Healthcare Diagnostics Inc
IVDs, clinical chemistry instrumentation. ADVIA LabCell and ADVIA WorkCell CDX Systems: 040-A001-XX.FSN February 2013 (33Kb)
MHRA ref: 2013/002/007/601/009
Siemens Medical Solutions Diagnostics
IVDs, clinical chemistry reagent. Immulite and Immulite 1000, third generation TSH (thyroid-stimulating hormone). FSN February 2013 (28Kb).
MHRA ref: 2013/002/005/601/003
Ultrasound, imaging accessory. Aixplorer. FSN 10 January 2013 (558Kb).
MHRA ref: 2013/002/014/081/002
Spinal implants, pedicle screw. Occipital screw 4.5mm, length 8mm, titanium alloy (TAN) – 04.601.108, 04.601.108S. FSN 11 February 2013 (1197Kb).
MHRA ref: 2013/002/011/291/010
Thermo Fisher Scientific
IVDs, bacteriology reagent. Oxoid antimicrobial susceptibility testing disc. FSN 07 February 2013 (27Kb)
MHRA ref: 2013/002/007/601/005
Standalone diagnostic workstation. Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect), Vitrea fX, and VitreaLT. FSN 05 February 2013 (79Kb).
MHRA ref: 2013/002/008/081/006
Vital Signs (supplier: GE Healthcare)
Diagnostic measurement and monitoring; thermometer, electronic. Vital – Temp* general purpose probe (Vital Signs disposable general purpose 9 French temperature probes) – 1016, 1016EU, GXXXXX64. FSN 19 December 2012 (174Kb). Update to: FSN October 2012 (162Kb).
MHRA ref: 2012/009/026/291/015