Home › Device types › GBS
Catheter, Ventricular, General & Plastic Surgery
FDA product code GBS · Class 1 · General, Plastic Surgery
220
Registered devices
32
Adverse events
20
Recalls
27
510(k) clearances
Devices with this code
Argyle — Cardinal Health, Inc.Argyle — Cardinal Health, Inc.Axiom® PVC — AXIOM MEDICAL, INCORPORATEDAxiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATEDAxiom® PVC — AXIOM MEDICAL, INCORPORATEDAxiom® Sump-n-Sheath® Atraum® With ClotStop® — AXIOM MEDICAL, INCORPORATEDSilicone Thoracic Drain, S Type — FORTUNE MEDICAL INSTRUMENT CORP.Silicone Thoracic Drain, S Type — FORTUNE MEDICAL INSTRUMENT CORP.Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATEDThoracic Drain — LIVANOVA USA, INC.Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATEDAxiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATEDAxiom® Uni-Sump Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATEDAxiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATEDAxiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATEDDiversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATEDAxiom® CWV Sump Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATEDAxiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATEDThoracic Drain — LIVANOVA USA, INC.Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATEDThoracic Drain — LIVANOVA USA, INC.Silicone Thoracic Drain, SF Type — FORTUNE MEDICAL INSTRUMENT CORP.Silicone Thoracic Drain, S Type — FORTUNE MEDICAL INSTRUMENT CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-08-10 | Atrium Medical Corporation | Mislabeled: One lot of 32Fr Straight Catheters packaged and labeled as 24Fr Straight Catheters. |
| 2010-08-10 | Atrium Medical Corporation | Mislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters. |
| 2009-02-27 | Concentric Medical Inc | Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing. |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparinc allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
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