1,392 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400
FDA Enforcement
Class II
·Ongoing·Hamilton Co·March 10, 2021
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620 SOMATOM go.Up Model 11061628 NA* SOMATOM go.All Model 11061630 SOMATOM go.All Model 11061638 NA* SOMATOM go.Top Model 11061640 SOMATOM go.Top Model 11061648 NA* SOMATOM X.cite Model 11330001 SOMATOME X.ceed Model 11330002 SOMATOM go.Sim Model 11061660 NA* SOMATOM go.Open Pro Model 11061670 NAEOTOM Alpha Model 11330003
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 1, 2023
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
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
FDA Enforcement
Class I
·Ongoing·Covidien LP·August 23, 2023