Panels › General Hospital › Product code BRZ · Class 2
Set, Blood Transfusion
Regulation 880.5440
0510(k)s in 12 months (30 all time)
0recalls in 12 months (24 all time)
23recalls that name a 510(k)
Top companies in BRZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Hospira Inc. | 0 | 13 |
| Baxter Healthcare Corp | 3 | 8 |
| Genesis BPS, LLC. | 0 | 3 |
| The Boston Medical Group | 2 | 0 |
| Puritas Health Care, Inc. | 2 | 0 |
| Alpha Therapeutic Corp. | 1 | 0 |
| Amkor Trading Co. | 1 | 0 |
| Arteriocyte Medical Systems, Inc. | 1 | 0 |
| Blood Products Specialties, LLC | 1 | 0 |
| Cardinal Health, Alaris Products | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 17, 2022 | K220558 | Blood Administration Sets Baxter Healthcare Corporation | BRZ |
| Jun 10, 2021 | K210335 | Blood Administration Set Baxter Healthcare Corporation | BRZ |
| Oct 4, 2013 | K132905 | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER Arteriocyte Medical Systems, Inc. | BRZ |
| Apr 10, 2009 | K083349 | BLOOD TRANSFUSION SET Shan Dong Wei Gao Group Medical Polymer Products, CN | BRZ |
| Mar 3, 2008 | K073339 | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR Fenwal, Inc. | BRZ |
| Jun 30, 2005 | K041496 | PENTATRASFU BLOOD TRANSFUSION SETS Pentaferte S.P.A | BRZ |
| Jun 20, 2005 | K050805 | 30 ML OR 60 ML PEDI-SYRINGE FILTER Blood Products Specialties, LLC | BRZ |
| Apr 1, 2005 | K050115 | BLOOD HAND PUMP ADMINISTRATION SET Cardinal Health, Alaris Products | BRZ |
| Nov 7, 2002 | K023039 | BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 Tuta Healthcare Pty Limited, AU | BRZ |
| Aug 15, 2000 | K000685 | CHARTER MEDICAL NEONATAL SYRINGE SET Charter Medical, Ltd. | BRZ |
| Nov 17, 1999 | K993120 | MODIFIED BLOOD RECIPIENT SET Baxter Healthcare Corp | BRZ |
| Dec 16, 1997 | K972843 | PROTOS BLOOD TRANSFUSION SET Globe Ent., Inc. | BRZ |
| Apr 21, 1994 | K940074 | Y-TYPE BLOOD ADMINISTRATION SET Puritas Health Care, Inc. | BRZ |
| Apr 15, 1994 | K940055 | MULTISET Puritas Health Care, Inc. | BRZ |
| Dec 24, 1992 | K921595 | Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 Haemotronic, Inc. | BRZ |
| Jun 4, 1992 | K920788 | BLOOD ADMINISTRATION SET Douglas Medical Products Corp. | BRZ |
| Feb 16, 1988 | K880174 | JMS TRANSFUSION SET Jms Co., Ltd., JP | BRZ |
| Jul 27, 1987 | K871908 | IV ADMINISTRATION SET Travenol Laboratories, S.A. | BRZ |
| Jan 20, 1987 | K864441 | CHURCHILL BLOOD ADMINISTRATION SET Churchill Corp. | BRZ |
| May 27, 1986 | K861523 | STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025) Jufrey Multimed Corp. | BRZ |
| Jan 9, 1986 | K854562 | CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I Medelec Intl. Corp. | BRZ |
| Nov 18, 1985 | K852167 | ISOVOL-EXCHANGE TRAY Rocky Mountain Medical Corp. | BRZ |
| Aug 22, 1985 | K853386 | MULTISET 40 Migada, Ltd., IL | BRZ |
| May 3, 1985 | K851477 | VYGON EXCHANGE TRANSFUSION TRAY 275.00 Vygon Corp. | BRZ |
| Aug 30, 1984 | K841561 | HESUNG'S BLOOD DONOR SETS Amkor Trading Co. | BRZ |
| Jun 22, 1984 | K841187 | BLOOD COLLECTION SET, STERILE, DISPOS. Marbex, Inc. | BRZ |
| Mar 19, 1984 | K840411 | BLOOD & PLASMA ADMIN. DEV-STERILE Loversan | BRZ |
| Dec 27, 1983 | K833294 | ALPHA Y-RECIPIENT SET Alpha Therapeutic Corp. | BRZ |
| Sep 30, 1982 | K822410 | BOSTON BLOOD DONOR SETS The Boston Medical Group | BRZ |
| Sep 30, 1982 | K822409 | BOSTON BLOOD TRANSFUSION SETS The Boston Medical Group | BRZ |
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