10,000 results
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23ms
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Sources: EU EUDAMED, US FDA
Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
FDA Enforcement
Class II
·Terminated·Irvine Biomedical Inc, a St. Jude Medical Co.·September 30, 2020
Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
FDA Enforcement
Class II
·Terminated·Irvine Biomedical Inc, a St. Jude Medical Co.·September 30, 2020
US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.
FDA Enforcement
Class II
·Terminated·St. Jude Medical·November 13, 2013
Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
FDA Enforcement
Class II
·Ongoing·Tenderneeds Fertility LLC·August 11, 2021
RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·December 31, 2014
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·May 22, 2013
iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·September 2, 2015
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
FDA Enforcement
Class II
·Ongoing·Tenderneeds Fertility LLC·August 11, 2021
2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
FDA Enforcement
Class II
·Ongoing·Tenderneeds Fertility LLC·August 11, 2021
Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
FDA Enforcement
Class II
·Terminated·ZOLL Circulation, Inc.·October 13, 2021
Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
FDA Enforcement
Class II
·Ongoing·Tenderneeds Fertility LLC·August 11, 2021
Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
FDA Enforcement
Class II
·Terminated·ZOLL Circulation, Inc.·October 13, 2021
ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
FDA Enforcement
Class II
·Terminated·ZOLL Circulation, Inc.·October 13, 2021
Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180
FDA Enforcement
Class II
·Terminated·ZOLL Circulation, Inc.·October 13, 2021
Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527
FDA Enforcement
Class II
·Terminated·ZOLL Circulation, Inc.·October 13, 2021
Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251
FDA Enforcement
Class II
·Terminated·ZOLL Circulation, Inc.·October 13, 2021
Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077
FDA Enforcement
Class II
·Terminated·ZOLL Circulation, Inc.·October 13, 2021
Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107
FDA Enforcement
Class II
·Terminated·ZOLL Circulation, Inc.·October 13, 2021
Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
FDA Enforcement
Class II
·Terminated·ZOLL Circulation, Inc.·October 13, 2021
11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
FDA Enforcement
Class II
·Terminated·Ii - Vi Incorporated·June 13, 2018