24 results
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8ms
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Sources: EU EUDAMED, US FDA
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA
FDA Enforcement
Class II
·Ongoing·Microcare Medical·October 2, 2024
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT 2.5CMX10CM 2 EA GRAFTON M, REF T42200INT; f) DBM T42200JPN GRAFTON MATRIX 2.5CM X10CM, REF T42200JPN; g) DBM T42210 2.5CMX5CM 2 EACH GRAFTON MATR, REF T42210; h) DBM T42210AUS 2.5CMX5CM 2 EA GRAFTON MX, REF T42210AUS; i) DBM T42210INT 2.5CMX5CM 2 EA GRAFTON M, REF T42210INT; j) DBM T42210JPN GRAFTON MATRIX 2.5CM X 5CM, REF T42210JPN; Demineralized Bone Matrix (DBM) product
FDA Enforcement
Class II
·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM T42275INT 8MMX1CMX10CM 2 EA GRFTON S, REF T42275INT; f) DBM T42275JPN GRAFTON MATRIX 1CM X 10CM, REF T42275JPN; g) DBM T42280 8MMX1CMX20CM 2 EACH GRAFTON M, REF T42280; h) DBM T42280AUS 8MMX1CMX20CM 2 EA GRFTON S, REF T42280AUS; i) DBM T42280INT 8MMX1CMX20CM 2 EA GRFTON S, REF T42280INT; j) DBM T42280JPN GRAFTON MATRIX 1CM X 20CM, REF T42280JPN; Demineralized Bone Matrix (DBM) product
FDA Enforcement
Class II
·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
FDA Enforcement
Class II
·Ongoing·Edwards Lifesciences, LLC·April 6, 2022
Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
FDA Enforcement
Class II
·Ongoing·Hologic, Inc·March 23, 2022
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·March 4, 2026
medex Arterial Kit 1/EA, Product Code REF MX7827
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
medex TranStar Single ICP Set 1/EA, Product Code REF MX20897
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 18, 2023
Functional MR V1.0
FDA Enforcement
Class II
·Ongoing·OLEA MEDICAL·October 25, 2023
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024
OEC 9900 Systems with 9-inch Image Intensifier
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023