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    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

    FDA Enforcement
    Class II ·Terminated·MEDLINE IND·January 18, 2017

    Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. Evera XT VR ICD DF1 (Product No. DVBB1D1); f. Evera XT VR ICD DF4 (Product No. DVBB1D4); EXPANSION: g. Evera S DR ICD DF4 (Product No. DDBC3D4); h. Evera XT DR ICD DF1 Gold (Product No. DDBB1D1G); i. Evera XT DR ICD DF4 (Product No. DDBB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

    FDA Enforcement
    Class I ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 28, 2018

    RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in the laryngeal area. The tube is resistant to the following kinds of laser: A R+ laser / ND/YAG laser / CO2 lasers (continuous-wave or pulsed) with a wave length ranging from 0.488 ¿m to 10.6 ¿m.

    FDA Enforcement
    Class II ·Terminated·TELEFLEX MEDICAL INC·July 15, 2020

    Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Product No. DDMC3D1); EXPANSION: e. Evera MRI S DR ICD DF4 (Product No. DDMC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

    FDA Enforcement
    Class I ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 28, 2018

    EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·January 27, 2021

    - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. 72200425 Lot 122631 - CLEAR-TRAC Flexible Cannula, Threaded, w/Obturator, (Orange) 6.5mm x 72mm Ref. 72200427 Lot 122465 - Crystal Cannula w/Obturator (Orange) 5.75mm I.D. X 7cm Ref. AR-6460 Lot 122594, 122518 - Crystal Cannula, Partially Threaded, Distal End, w/Obturator, (Orange) 5.75mm I.D. x 7cm Ref. AR-6564 Lot 122493 - Dry-Doc Cannula System w/ Obturator (Translucent Green) 5.0mm x 85mm Ref. C7350 Lot 123263 - Dry-Doc Cannula w/ Obturator (Translucent Blue) 7.0mm x 85mm Ref. C7360 Lot 123263, 122594 - Instrument Cannula w/Obturator w/"No Squirt Cap", (Purple) 7.0mm I.D. X 7cm Ref. AR-6550 Lot 122590 - Partially Threaded Cannula and Obturator, w/o "No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6567* Lot 123043, 122278 - PassPort Button Cannula" (Blue) 8mm ID x 4cm Ref. AR-6592-08-40 Lot 122594 - Smooth Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214106 Lot 122465 - Threaded Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214108 Lot 122665 - Threaded Clear Cannula w/Obturator (Yellow) 8.5mm x 75mm Ref. 214120 Lot 122440, 122588 - Threaded Clear Cannula w/Obturator, (Purple) 7.0mm x 75mm Ref. 214116 Lot 122465 - Tibial Tunnel Cannula, Accomodates 9-12 mm Tunnel Diameters, (Blue) Ref. AR-1802D Lot 122594, 122279 - Twist-In Cannula w/Obturator w/"No Squirt Cap", (Gold) 8.25mm I.D. X 7cm Ref. AR-6530 Lot 122590, 123190, 122665 - Twist-In Cannula w/Obturator, w/ "No-Squirt" Cap, (Green) 6.0mm I.D. x 7cm Ref. AR-6535 Lot 122590, 122665 - Twist-In Cannula w/Obturator, w/"No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6570 Lot 123190 - Twist-In Cannula w/Obturator, w/o "No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6570* Lot 123043 - Twist-In Cannula w/Obturator, w/o No Squirt Cap, (Gold) 8.25mm I.D. x 7cm Ref. AR-6530* Lot 122504, 122493, 123043 - Universal Cannula w/Obturator, 76mm long (Green) 7.0mm Ref. 012421 Lot 123043 - Universal Cannula, w/Obturator and Trocar (Blue) 5.0mm I.D. x 76mm Ref. 012405 Lot 123043, 122434 Arthoscope

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·February 15, 2017

    Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.

    FDA Enforcement
    Class II ·Terminated·Bock,Otto,Orthopedic Ind,Inc·March 26, 2014

    Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

    FDA Enforcement
    Class I ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 28, 2018

    Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·May 18, 2016

    ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·August 14, 2019

    Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No. DVFC3D1); d. Visia AF MRI VR SureScan DF4 (Product No. DVFC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

    FDA Enforcement
    Class I ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 28, 2018

    ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·August 14, 2019

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·August 14, 2019

    Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·March 25, 2020

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·August 28, 2013

    EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·August 23, 2017

    EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·August 23, 2017