62 results
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8ms
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Sources: EU EUDAMED, US FDA
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
FDA Enforcement
Class I
·Ongoing·DJO, LLC·October 13, 2021
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
FDA Enforcement
Class I
·Ongoing·DJO, LLC·October 13, 2021
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
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION: f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1); g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1); h. Viva S CRT-D DF4 (Product No. DTBB1D4) 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
CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023