Company
C.R. Bard Access Systems, Inc
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
30recalls (0 in 12 months)
30recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire", REF 006036, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., FASTRAC Guidewire Gastric Access Port Kit, REF 005739, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" REF 003030, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 003029, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, Sterile, Rx only, REF 000793, 20F. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) Kit with Soft Silicone Retention Dome, Sterile, Rx only, REF 000792, 20F. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, REF 000628, 20F. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) Kit with Soft Silicone Retention Dome, REF 000627, 20F. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Kit, REF 007082, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007078, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007056, 14F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007052, 16F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007050, 24F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007038, 14F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007037, 16F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007036, 24F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 007035, 24F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 007030, 24F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 007024, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007023, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 006035, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., FASTRAC* Guidewire Gastric Access Port Safety System, REF 006034, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., FASTRAC* "Pull" Gastric Access Port Safety System, REF 006033, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., FASTRAC "Pull" Gastric Access Port Kit, REF 005729, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" , REF 003028, 28F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull" REF 003027, 28F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull" REF 003025, 16F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Safety System Guidewire Placement Technique REF 000375, 20F, STERILE. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Safety System Ponsky "Pull" Placement Technique REF 000373, 20F, STERILE. Terminated |
KNT | K033562 K915841 +2 |
| Sep 20, 2007 | C.R. Bard Access Systems, Inc Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116. Terminated |
MPB | K844433 |