Bayer Healthcare

• NBW — Clinical Chemistry6 devices
• LFR — Clinical Chemistry2 devices
• JJX — Clinical Chemistry1 device

• Z-0927-2017 — MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.Class II·Terminated·2016-11-07
• Z-0400-2017 — PET Infusion PumpClass II·Terminated·2016-09-30
• Z-2768-2016 — Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applicationsClass II·Terminated·2016-08-02
• Z-2244-2016 — Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.Class II·Terminated·2016-06-09
• Z-0627-2016 — Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.Class II·Terminated·2015-11-30
• Z-2775-2015 — Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.Class II·Terminated·2015-08-04

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K150942 — Contour Next USB Blood Glucose Monitoring SystemCode NBW·2015-11-25
• K151742 — Contour Next Control SolutionCode JJX·2015-09-23
• K122370 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITORCode NBW·2013-09-26
• K121087 — CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEMCode NBW·2012-06-28
• K110894 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METERCode LFR·2012-03-28
• K111268 — CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEMCode LFR·2012-03-06
• K091820 — CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEMCode NBW·2009-08-26
• K062058 — ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080Code NBW·2006-09-11
• K060470 — ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080Code NBW·2006-04-12