1,393 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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Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured
FDA Enforcement
Class II
·Ongoing·Nova Biomedical Corporation·November 8, 2023
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 63368
FDA Enforcement
Class II
·Ongoing·Nova Biomedical Corporation·November 8, 2023
Navik 3D v2, REF NAVIK3D, 3D Mapping System
FDA Enforcement
Class III
·Ongoing·APN Health LLC·December 20, 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