1,392 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, Item Number 949000221; 5) FDS,135,NV,MICRO-CHAMBER,W/FILTER,YELLOW, Item Number 949000223
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 22, 2025
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
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
FDA Enforcement
Class I
·Ongoing·Covidien LP·August 23, 2023
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
FDA Enforcement
Class I
·Ongoing·Covidien LP·August 23, 2023
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP
FDA Enforcement
Class I
·Ongoing·Covidien LP·August 23, 2023