1,339 results
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient¿¿"s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient¿¿"s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient¿¿"s use of the system. The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs
FDA Enforcement
Class II
·Terminated·Nuvectra·May 11, 2016
DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
FDA Enforcement
Class II
·Terminated·DRG Instruments GmbH·August 14, 2019
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
FDA Enforcement
Class II
·Ongoing·Fujirebio Diagnostics, Inc.·February 11, 2026
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: The ¿-Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: Liquid (Frozen), 1 ¿ 1.5 mL (4 Concentrations) CAL 1 0 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 2 30 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 3 100 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 4 1000 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 950. Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
FDA Enforcement
Class II
·Ongoing·Fujirebio Diagnostics, Inc.·February 11, 2026
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
FDA Enforcement
Class II
·Ongoing·Covidien, LP·June 10, 2026
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)
FDA Enforcement
Class II
·Ongoing·Covidien LP·November 6, 2024
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.
FDA Enforcement
Class II
·Ongoing·Covidien, LP·May 8, 2024
Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
FDA Enforcement
Class II
·Ongoing·Covidien LP·February 14, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
FDA Enforcement
Class II
·Ongoing·Covidien, LP·June 5, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
FDA Enforcement
Class II
·Ongoing·Covidien, LP·March 15, 2023
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
FDA Enforcement
Class II
·Ongoing·Covidien, LP·June 23, 2021