Panels › General, Plastic Surgery › Product code GBX · Class 1
Catheter, Irrigation
Regulation 878.4200
0510(k)s in 12 months (77 all time)
7recalls in 12 months (83 all time)
3recalls that name a 510(k)
Top companies in GBX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 53 |
| Degania Silicone, Ltd. | 0 | 10 |
| Rocket Medical Plc | 0 | 6 |
| Navarre Biomedical , Ltd. | 5 | 0 |
| Sil-Med Corp. | 5 | 0 |
| Axiom Medical, Inc. | 3 | 0 |
| Hospira Inc. | 0 | 3 |
| Kendall Healthcare Products Co. Div.Of Tyco Health | 3 | 0 |
| Mikro-Tek Laboratories | 3 | 0 |
| Baxter Healthcare Corp | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar
Product Number: JP-2189
An introduction/drainage catheter is a device that is a flexible single or multilumen tube inten Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes
Cardinal Health PN: JP-2188
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be u Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 15FR
Cardinal PN:JP-2223
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce no Terminated |
GBX | None listed |
| Jun 11, 2018 | Cardinal Health 200, LLC Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Terminated |
GBX | None listed |
| Jun 11, 2018 | Cardinal Health 200, LLC Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Terminated |
GBX | None listed |
| Jun 11, 2018 | Cardinal Health 200, LLC Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Manufactured For Cardinal Health, Waukegan, IL. Terminated |
GBX | None listed |
| Jun 11, 2018 | Cardinal Health 200, LLC Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210, packaged 1/box, 12 boxes/case, single use, RX, Sterile. . Terminated |
GBX | None listed |
| Jun 11, 2018 | Cardinal Health 200, LLC Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Terminated |
GBX | None listed |
| Jun 11, 2018 | Cardinal Health 200, LLC Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Terminated |
GBX | None listed |
| Jun 11, 2018 | Cardinal Health 200, LLC Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Terminated |
GBX | None listed |
| Jun 11, 2018 | Cardinal Health 200, LLC Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Terminated |
GBX | None listed |
| Jun 11, 2018 | Cardinal Health 200, LLC Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Terminated |
GBX | None listed |
| Jun 11, 2018 | Cardinal Health 200, LLC Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Terminated |
GBX | None listed |
| Jun 11, 2018 | Cardinal Health 200, LLC Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Terminated |
GBX | None listed |
| Feb 20, 2018 | Degania Silicone, Ltd. Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234.
Used for the drainage of body fluids for surgical use. Terminated |
GBX | None listed |
| Apr 21, 2017 | Cardinal Health 200, LLC Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound dra Terminated |
GBX | None listed |
| Apr 21, 2017 | Cardinal Health 200, LLC Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound dra Terminated |
GBX | None listed |
| Apr 21, 2017 | Cardinal Health 200, LLC Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only.
Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage syst Terminated |
GBX | None listed |
| Apr 21, 2017 | Cardinal Health 200, LLC Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a Terminated |
GBX | None listed |
| Apr 21, 2017 | Cardinal Health 200, LLC Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only.
Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage syst Terminated |
GBX | None listed |
| Apr 21, 2017 | Cardinal Health 200, LLC Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For Single Use Only.
Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage syst Terminated |
GBX | None listed |
| Apr 21, 2017 | Cardinal Health 200, LLC Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only.
Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound d Terminated |
GBX | None listed |
| Apr 21, 2017 | Cardinal Health 200, LLC Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound d Terminated |
GBX | None listed |
| Apr 21, 2017 | Cardinal Health 200, LLC Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only.
Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage syst Terminated |
GBX | None listed |
| Feb 22, 2017 | Degania Silicone, Ltd. Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx
Distributed by Cardinal Health, USA
Catalog Number: JP-2187
For wound drainage. Terminated |
GBX | None listed |
| May 16, 2014 | Hospira Inc. LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira
Prod Terminated |
GBX | K841362 |
| May 16, 2014 | Hospira Inc. LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira
Product Usage:
For Use With Flexible Irriga Terminated |
GBX | None listed |
| May 16, 2014 | Hospira Inc. LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira
Product Usage:
For us Terminated |
GBX | None listed |
| Sep 27, 2012 | Linvatec Corp. dba ConMed Linvatec Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set***
This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-i Terminated |
GBX | None listed |
| Jan 7, 2011 | Merit Medical Systems, Inc. Merit One Step Centesis Drainage Catheter
Intended for the percutaneous drainage of fluids Terminated |
GBX | None listed |
| Sep 21, 2005 | C.R. Bard, Inc., Urological Division Bard * Davol Reliavac 400 Closed Wound Suction Kit * Sterile/EO * Single use * Medium-Large 3/16'' (15 Fr., 4.7mm) O.D. PVC Drain * 12.5'' (31.7cm) Hole Pattern, X-ray Opaque Stripe Attached Trocar * Terminated |
GBX | None listed |
| Aug 25, 2004 | Cardinal Health Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component of the wound drain system, individually packaged, 10 reservoirs per case; catalog #SU130-10 Terminated |
GBX | None listed |
| Mar 12, 2003 | Medline Industries Inc Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case Terminated |
GBX | K822510 |
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