FDA Product Code
FDA Product Code LHI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5440
510(k) Clearances — 206 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K033682 | SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE | Laboratorios Grifols, S.A. | 2003-12-17 | Traditional | PDF ↗ |
| K031861 | MIX2VIAL TRANSFER DEVICE | Medimop Medical Projects, Ltd. | 2003-07-29 | Traditional | PDF ↗ |
| K024239 | CHEMO DISPENSING PIN, MODEL 12495 | Abbott Laboratories | 2003-01-13 | Special | PDF ↗ |
| K023539 | STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW | Valumed | 2002-12-17 | Traditional | PDF ↗ |
| K023747 | PHASEAL | Carmel Pharma Ab. | 2002-11-15 | Special | PDF ↗ |
| K022523 | RAPID-FILL TUBESET, MODEL 90005 | Baxa Corp. | 2002-08-12 | Traditional | PDF ↗ |
| K012189 | ANGELTOUCH VENTED IV ADMINISTRATION SET | Angiplast Private , Ltd. | 2002-03-05 | Traditional | PDF ↗ |
| K013523 | CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 | Shire Biologics, Inc. | 2002-01-07 | Traditional | PDF ↗ |
| K013087 | SINGLE DOSE DISPENSING PIN, MODEL 2201 | Alaris Medical Systems, Inc. | 2001-11-13 | Traditional | PDF ↗ |
| K010703 | INTER-VIAL | Duoject Medical Systems, Inc. | 2001-06-25 | Traditional | PDF ↗ |
| K010623 | RECONSTITUTION KIT & VIAL CONNECTOR | Bioject, Inc. | 2001-04-05 | Traditional | PDF ↗ |
| K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 | Baxa Corp. | 2001-03-28 | Traditional | PDF ↗ |
| K003730 | CHEMO-AIDE DISPENSING PIN | Baxter Healthcare Corp | 2000-12-20 | Traditional | PDF ↗ |
| K001831 | NEEDLELESS TRANSFER DEVICE | Medimop Medical Projects, Ltd. | 2000-07-11 | Traditional | PDF ↗ |
| K001368 | PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER | Carmel Pharma Ab. | 2000-05-12 | Special | PDF ↗ |
| K001293 | MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE | Medimop Medical Projects, Ltd. | 2000-05-05 | Special | PDF ↗ |
| K994323 | KAWASUMI LABORATORIES PHILEBOTOMY SET | Kawasumi Laboratories Co., Ltd. | 2000-03-08 | Traditional | PDF ↗ |
| K000367 | SECURMIX | Eurospital | 2000-02-29 | Traditional | PDF ↗ |
| K990711 | CODAN CHEMOSPIKE | Codan US Corp. | 1999-04-13 | Traditional | PDF ↗ |
| K983794 | CHEMO MINI SPIKE PLUS | B. Braun of America, Inc. | 1999-03-23 | Traditional | PDF ↗ |
| K980587 | IV DECANTER-FLEXIBLE | Inrad | 1998-04-17 | Traditional | PDF ↗ |
| K980381 | PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO | Carmel Pharma Ab. | 1998-03-03 | Traditional | PDF ↗ |
| K974431 | CHEMO-SPIKE II RECONSTITUTION DEVICE | Medi-Dose, Inc. | 1998-01-08 | Traditional | PDF ↗ |
| K974198 | TAKY-SPIKE PLUS | Clinico | 1997-12-22 | Traditional | PDF ↗ |
| K973654 | VIAL-MATE RECONSTITUTION DEVICE (2B8071) | Baxter Healthcare Corp | 1997-10-24 | Traditional | PDF ↗ |
| K961008 | AUTOMIX 3+3/AS COMPOUNDER SYSTEM | Baxter Healthcare Corp | 1997-10-10 | Traditional | PDF ↗ |
| K972134 | BAG DECANTER | Remington Medical, Inc. | 1997-08-26 | Traditional | PDF ↗ |
| K972117 | MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW | Medical Specialty Innovations, Inc. (Msi) | 1997-08-26 | Traditional | PDF ↗ |
| K955622 | AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; | Baxter Healthcare Corp | 1997-05-06 | Traditional | PDF ↗ |
| K970789 | SAFE-CONNECT VIAL DISPENSING SPIKE | Faulding Medical Device Co. | 1997-05-01 | Traditional | PDF ↗ |
| K964989 | CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) | Critical Device Corp. | 1997-04-02 | Traditional | PDF ↗ |
| K970359 | COMBIPROT EMERGENCY ENFUSION DEVICE | B.Braun Medical, Inc. | 1997-03-18 | Traditional | PDF ↗ |
| K963012 | BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) | Bioject, Inc. | 1996-10-15 | Traditional | PDF ↗ |
| K963583 | MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE | Medimop Medical Projects, Ltd. | 1996-10-07 | Traditional | PDF ↗ |
| K960466 | IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) | Abbott Laboratories | 1996-05-29 | Traditional | PDF ↗ |
| K960921 | CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE | Codan Medlon, Inc. | 1996-04-17 | Traditional | PDF ↗ |
| K955398 | FORMULATION PREPARATION DEVICE | B.Braun Medical, Inc. | 1996-04-04 | Traditional | PDF ↗ |
| K955594 | SAFELINE I.V. BAG ACCESS DEVICE | Mcgaw, Inc. | 1996-03-06 | Traditional | PDF ↗ |
| K955595 | SAFELINE MULTIDOSE VIAL ADAPTER | Mcgaw, Inc. | 1996-03-06 | Traditional | PDF ↗ |
| K955896 | MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 | Critical Device Corp. | 1996-02-06 | Traditional | PDF ↗ |
| K950305 | QTMICRO(TM) SYSTEM | Q.I. Medical, Inc. | 1995-10-13 | Traditional | PDF ↗ |
| K943095 | IV TRANSFER SPIKE | Migada, Ltd. | 1994-09-30 | Traditional | PDF ↗ |
| K943181 | DISPENSING PIN WITH ONE-WAY VALVE | B. Braun of America, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K935532 | TRANSFER SET | Puritas Health Care, Inc. | 1994-04-04 | Traditional | PDF ↗ |
| K935274 | DIPRIVAN LUER CONNECTOR | Ohmeda Medical | 1994-03-15 | Traditional | PDF ↗ |
| K926071 | ONCO-VIAL ADAPTER | David Bull Laboratories, USA, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K932462 | VENTED NEEDLE | Excel Medical, Inc. | 1993-09-15 | Traditional | PDF ↗ |
| K923782 | TRANSFER SET | Pacific Device, Inc. | 1993-07-02 | Traditional | PDF ↗ |
| K923966 | SYRINGE ADAPTOR | Excel Medical, Inc. | 1993-06-18 | Traditional | PDF ↗ |
| K924064 | INTERLINK UNIVERSAL VIAL ADAPTER | Baxter Healthcare Corp | 1993-04-21 | Traditional | PDF ↗ |
| K925401 | IV FLUID TRANSFER PIN | B. Braun of America, Inc. | 1993-03-03 | Traditional | PDF ↗ |
| K920015 | QUICKTEST SYSTEM | Q.I. Medical, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K921031 | EDGE MEDICAL DISPENSING PIN | Edgewater Medical Center | 1992-10-19 | Traditional | PDF ↗ |
| K921365 | NUTRIMIX MICROCOMPOUNDER | Abbott Laboratories | 1992-06-30 | Traditional | PDF ↗ |
| K913985 | TRANSFER-AID(TM) | Healthtek, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K912771 | ACACIAS PHARM/PUMP | Acacia, Inc. | 1992-02-14 | Traditional | PDF ↗ |
| K913804 | EXCELSIOR SINGLE LEAD DISPENSING SET | Excel Medical, Inc. | 1992-02-11 | Traditional | PDF ↗ |
| K902853 | GRAVITY PLUS CONTROLLER/COMPOUNDER | Fergy Corp. | 1991-05-09 | Traditional | PDF ↗ |
| K905116 | PHARM-ASSIST | Excel Medical, Inc. | 1991-04-25 | Traditional | PDF ↗ |
| K910213 | NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION | Abbott Laboratories | 1991-04-16 | Traditional | PDF ↗ |
| K910793 | RECONSTITUTION DEVICE | Baxter Healthcare Corp | 1991-03-21 | Traditional | PDF ↗ |
| K905201 | TPN FLUID TRANSFER SET | Mcgaw, Inc. | 1991-01-02 | Traditional | PDF ↗ |
| K904855 | ADD-A-VIAL | Kendall Mcgaw Laboratories, Inc. | 1990-11-19 | Traditional | PDF ↗ |
| K903159 | VALVE CONTROLLER FOR MICROMACRO COMPOUNDER | Baxa Corp., Sub. of Cook Group, Inc. | 1990-11-07 | Traditional | PDF ↗ |
| K904225 | KWIKMIX | Baxa Corp., Sub. of Cook Group, Inc. | 1990-11-05 | Traditional | PDF ↗ |
| K895922 | METRICARE EMPTY CONTAINER SYSTEMS | Metrix Co. | 1990-08-22 | Traditional | PDF ↗ |
| K900865 | ADD-A-VIAL II BINARY CONNECTOR | Kendall Mcgaw Laboratories, Inc. | 1990-07-11 | Traditional | PDF ↗ |
| K901063 | LUER LOCK TRANSFER PIN | Acacia, Inc. | 1990-07-06 | Traditional | PDF ↗ |
| K902482 | VITALMIX (SET & BAG) | Pacific Device, Inc. | 1990-07-02 | Traditional | PDF ↗ |
| K901404 | NUTRIMIX MACRO TPN COMPOUNDER | Abbott Laboratories | 1990-06-26 | Traditional | PDF ↗ |
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP | Baxa Corp., Sub. of Cook Group, Inc. | 1990-04-18 | Traditional | PDF ↗ |
| K896990 | PHARMULATOR | Acacia, Inc. | 1990-03-23 | Traditional | PDF ↗ |
| K890205 | AUTOMIX COMPOUNDER Y - ADAPTOR SET | Stedim, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K890204 | AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR | Stedim, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K894827 | AUTOMIX 3+3 COMPOUNDER | Baxter Healthcare Corp | 1989-10-06 | Traditional | PDF ↗ |
| K884626 | MODIFIED SLIDING RECONSTITUTION DEVICE | Baxter Healthcare Corp | 1988-11-22 | Traditional | PDF ↗ |
| K874495 | ADCOMP 4000 HP SYSTEM | Healthtek, Inc. | 1988-02-16 | Traditional | PDF ↗ |
| K872446 | MODIFIED INSTAFIL | Instafil, Inc. | 1987-08-25 | Traditional | PDF ↗ |
| K860610 | ADCOMP | Healthtek, Inc. | 1986-07-08 | Traditional | PDF ↗ |
| K860703 | U - STAR (MICRO-STAR) | Corning Costar Corp. | 1986-05-06 | Traditional | PDF ↗ |
| K861434 | MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG | Churchill Corp. | 1986-05-01 | Traditional | PDF ↗ |
| K860595 | TRANSFER SET | Migada, Ltd. | 1986-04-07 | Traditional | PDF ↗ |
| K860434 | CHEMO-VENT | Intl. Medical Industries | 1986-02-12 | Traditional | PDF ↗ |
| K860113 | DOUBLE-JECT TRANSFER NEEDLE | Medimix Products, Inc. | 1986-02-12 | Traditional | PDF ↗ |
| K854556 | TRANSFER NEEDLE | Soma Intl., Inc. | 1986-01-16 | Traditional | PDF ↗ |
| K854008 | STATLOCK | Healthtek, Inc. | 1985-11-13 | Traditional | PDF ↗ |
| K853830 | SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST | Travenol Laboratories, S.A. | 1985-11-06 | Traditional | PDF ↗ |
| K852467 | VIAL VENT FILTER | Baxter Healthcare Corp | 1985-10-17 | Traditional | PDF ↗ |
| K853075 | MEDNOVA SAFETY BAG | Mednova Corp. | 1985-10-16 | Traditional | PDF ↗ |
| K853212 | FLOW EASE(PLASTIC VENTED NEEDLE) | Acacia, Inc. | 1985-09-19 | Traditional | PDF ↗ |
| K853188 | TRANSFER DEVICE | Advance Medical Designs, Inc. | 1985-08-21 | Traditional | PDF ↗ |
| K852882 | MAXIFILL TRANSFER SET | Lyphomed, Inc. | 1985-08-16 | Traditional | PDF ↗ |
| K850757 | TANDEM SETS I.V. | Acacia, Inc. | 1985-04-04 | Traditional | PDF ↗ |
| K850051 | VERSA-FILL 120 & FILL SET 42-50 | Intl. Medical Industries | 1985-03-06 | Traditional | PDF ↗ |
| K844904 | CYTOSAFE NEEDLE | Baxa Corp., Sub. of Cook Group, Inc. | 1985-02-22 | Traditional | PDF ↗ |
| K843639 | ADD-A-VIAL SOLUTION TRANSFER DEVICE | American Mcgaw | 1985-01-14 | Traditional | PDF ↗ |
| K844340 | TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP | Travenol Laboratories, S.A. | 1985-01-09 | Traditional | PDF ↗ |
| K842345 | MAXIFILL TRANSFER SET | Lyphomed, Inc. | 1984-08-17 | Traditional | PDF ↗ |
| K834500 | SOLUTION TRANSFER SET | Berlex Laboratories, Inc. | 1984-02-17 | Traditional | PDF ↗ |
| K832347 | TWOFER NEEDLE | Baxa Corp., Sub. of Cook Group, Inc. | 1983-09-12 | Traditional | PDF ↗ |
Product code LHI · Class II · General Hospital. Data: openFDA.