77 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor provides a means to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network.
FDA Enforcement
Class II
·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·April 1, 2015
Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
FDA Enforcement
Class II
·Terminated·Data Innovations, LLC·October 31, 2018
MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code FPA·November 6, 2009
Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code FPA·November 6, 2009
Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code FPA·November 6, 2009
BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FPA·February 19, 2015
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
FDA Enforcement
Class II
·Terminated·WRP Asia Pacific Sdn Bhd·June 6, 2018
Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 The driver is intended to be used in conjunction with compression and locking bone screws for fixation of long bone fractures when Kinamed Trochanteric Grips & Cable-Plates are used. Subsequent Product Codes: HWC, JDQ.
FDA Recall
Terminated
·Kinamed Inc·Product code KTT·August 18, 2010