FDA 510(k) Applications for Medical Device Product Code "FIB"
(Protector, Transducer, Dialysis)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K240164 | Bain Medical Equipment (Guangzhou) Co., Ltd. | NovaLine SP-C35 Transducer Protector (956007) | 06/28/2024 |
| K964337 | CIRCULATORY TECHNOLOGY, INC. | BETTER-BLADDER (BB) | 05/23/1997 |
| K000702 | FRESENIUS MEDICAL CARE NORTH AMERICA | BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR | 06/07/2000 |
| K003445 | FRESENIUS MEDICAL CARE NORTH AMERICA | FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 | 12/01/2000 |
| K970536 | MEDISYSTEMS CORP. | MEDISYSTEMS TRANDUCER PROTECTOR | 05/12/1997 |
| K983076 | MEDISYSTEMS CORP. | MEDISYSTEMS TRANSDUCER PROTECTOR | 11/25/1998 |
| K001465 | NIPRO MEDICAL CORP. | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET | 12/05/2000 |
| K010264 | NIPRO MEDICAL CORP. | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET | 04/27/2001 |
| K072988 | NIPRO MEDICAL CORPORATION | NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 | 02/21/2008 |
| K001971 | OFI BIOMEDICA S.P.A. | HEMODIALYSIS TUBING SETS | 05/24/2001 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
