FDA Product Code
FDA Product Code FMF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5860
510(k) Clearances — 752 records · page 7 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K870078 | ACCUPEN(R) | Ulster Scientific, Inc. | 1987-03-17 | Traditional | PDF ↗ |
| K870018 | E-Z JECT INSULIN SYRINGE | Can-Am Surgical Corp. | 1987-02-04 | Traditional | PDF ↗ |
| K861686 | NOVOPEN SYSTEM (INSULIN SYRINGE) | Squibb-Novo, Inc. | 1987-01-21 | Traditional | PDF ↗ |
| K864541 | BT HYPODERMIC SYRINGE | Baron Technologies, Inc. | 1987-01-21 | Traditional | PDF ↗ |
| K864407 | REFILLABLE SYRINGE | Med Fusion Systems, Inc. | 1987-01-20 | Traditional | PDF ↗ |
| K864777 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC | Mac Lee Medical Products | 1986-12-29 | Traditional | PDF ↗ |
| K864781 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC | Mac Lee Medical Products | 1986-12-29 | Traditional | PDF ↗ |
| K864779 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC | Mac Lee Medical Products | 1986-12-29 | Traditional | PDF ↗ |
| K864747 | VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES | Jms Co., Ltd. | 1986-12-29 | Traditional | PDF ↗ |
| K864778 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC | Mac Lee Medical Products | 1986-12-29 | Traditional | PDF ↗ |
| K864782 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC | Mac Lee Medical Products | 1986-12-23 | Traditional | PDF ↗ |
| K864780 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC | Mac Lee Medical Products | 1986-12-23 | Traditional | PDF ↗ |
| K864783 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC | Mac Lee Medical Products | 1986-12-23 | Traditional | PDF ↗ |
| K864414 | SEAL SYRINGE (3CC,5CC,12CC,20CC,30CC & 50CC) | Seal Syringe Corp. | 1986-12-18 | Traditional | PDF ↗ |
| K864761 | USI AUTOJECT INSULIN SYRINGE | Ulster Scientific, Inc. | 1986-12-16 | Traditional | PDF ↗ |
| K864555 | 3 RING ATTACHMENT | Professional Medical Services | 1986-12-01 | Traditional | PDF ↗ |
| K861276 | TAMPER PROOF CAP | Intl. Medical Industries | 1986-05-05 | Traditional | PDF ↗ |
| K861153 | DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES | Exel Intl. | 1986-04-23 | Traditional | PDF ↗ |
| K853450 | STERISTORAGE CONTAINER | K-Seven Industries, Inc. | 1986-03-18 | Traditional | PDF ↗ |
| K854877 | ACU-SYRINGE W/WO NEEDLES | Acuderm, Inc. | 1986-02-19 | Traditional | PDF ↗ |
| K854563 | DISPOSABLE SYRINGES & NEEDLES | Medelec Intl. Corp. | 1985-12-09 | Traditional | PDF ↗ |
| K853120 | ADDITIVE EXTENSION SYRINGE | Abbott Laboratories | 1985-12-05 | Traditional | PDF ↗ |
| K852503 | R.R. PRONTO SIRINGA | Medical Hospital Equipment | 1985-11-13 | Traditional | PDF ↗ |
| K854255 | SPAN / AID SYRINGE | Span-America Medical Systems, Inc. | 1985-11-12 | Traditional | PDF ↗ |
| K852444 | ASIK 'ONCE' SYRINGE | Pharma-Plast USA, Inc. | 1985-10-16 | Traditional | PDF ↗ |
| K852443 | PHARMA-PLAST CLINIPAK | Pharma-Plast USA, Inc. | 1985-10-16 | Traditional | PDF ↗ |
| K853838 | JMS LCC INSULIN SYRINGE | Jms Co., Ltd. | 1985-10-16 | Traditional | PDF ↗ |
| K852990 | PAO VALUE | Ackard Laboratories | 1985-09-20 | Traditional | PDF ↗ |
| K852304 | SAFE-N-JECT | Gerstner Intl. Trade | 1985-09-20 | Traditional | PDF ↗ |
| K852819 | STERILE DISPOSABLE SYRINGE(3 PIECES) | Fabersanitas, S.A. | 1985-09-20 | Traditional | PDF ↗ |
| K852818 | STERILE DISPOSABLE SYRINGES(2 PIECES) | Fabersanitas, S.A. | 1985-07-29 | Traditional | PDF ↗ |
| K851523 | DISPOSABLE PLASTIC SYRINGES | Transcoject GmbH & Co. KG | 1985-07-24 | Traditional | PDF ↗ |
| K852607 | MONJECT STERILE 20CC SYRINGES | Sherwood Medical Co. | 1985-07-23 | Traditional | PDF ↗ |
| K852588 | MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES | Sherwood Medical Co. | 1985-07-23 | Traditional | PDF ↗ |
| K852580 | MONOJECT STERILE 60CC SYRINGES | Sherwood Medical Co. | 1985-07-23 | Traditional | PDF ↗ |
| K852544 | MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES | Sherwood Medical Co. | 1985-07-23 | Traditional | PDF ↗ |
| K852640 | MONOJECT STERILE 35CC SYRINGES | Sherwood Medical Co. | 1985-07-23 | Traditional | PDF ↗ |
| K851464 | PULSE MED CUSTOM PKG. PROC. TRAYS OPERATING ROOMS | Pulse Med, Inc. | 1985-07-05 | Traditional | PDF ↗ |
| K851519 | FORTUNA DISPOSABLE SYRINGES | Impor-Tex, Intl., Inc. | 1985-06-17 | Traditional | PDF ↗ |
| K851090 | MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE | Sherwood Medical Co. | 1985-04-12 | Traditional | PDF ↗ |
| K851089 | MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES | Sherwood Medical Co. | 1985-04-12 | Traditional | PDF ↗ |
| K850958 | BLOOD GAS SAMPLER KIT | Churchill Corp. | 1985-04-10 | Traditional | PDF ↗ |
| K844475 | SPECIMEN COLLECTION & TRANSPORT SYSTEM | Portable Medical Laboratories, Inc. | 1985-02-06 | Traditional | PDF ↗ |
| K844106 | SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY | Abco Dealers, Inc. | 1985-01-14 | Traditional | PDF ↗ |
| K844796 | MICRO-BETA U100 SYRINGE | Orange Medical Instruments, Inc. | 1984-12-18 | Traditional | PDF ↗ |
| K843415 | TOP HYPODERMIC SYRINGE LUER LOCK | Top Surgical Manufacturers Co. | 1984-12-07 | Traditional | PDF ↗ |
| K843887 | IV JET | Nuclear Concepts, Inc. | 1984-12-07 | Traditional | PDF ↗ |
| K844306 | GAINOR MEDICAL SYRINGE | Gainor Medical | 1984-11-30 | Traditional | PDF ↗ |
| K843472 | PHARMA-PLAST SYRINGE WITH NEEDLE | Zimmar Consulting , Ltd. | 1984-10-31 | Traditional | PDF ↗ |
| K843473 | PHARMA-PLAST INSULIN SYRINGE | Zimmar Consulting , Ltd. | 1984-10-31 | Traditional | PDF ↗ |
| K843471 | PHARMA-PLAST SYRINGE | Zimmar Consulting , Ltd. | 1984-10-31 | Traditional | PDF ↗ |
| K843414 | TOP HYPODERMIC SYRINGE PISTON | Top Surgical Manufacturers Co. | 1984-09-07 | Traditional | PDF ↗ |
| K841949 | DOSE RELEASE OF STERILIZATION LOTS | Medcare Disp Products, Inc. | 1984-09-05 | Traditional | PDF ↗ |
| K842227 | AIMED DISPOSABLE SYRINGE, VARIOUS SIZES | Tech-Cons Ltd., Intl. | 1984-07-23 | Traditional | PDF ↗ |
| K841566 | HESUNG DISPOSABLE SYRINGE | Amkor Trading Co. | 1984-07-17 | Traditional | PDF ↗ |
| K841810 | MARK5 ARTERIAL BLOOD GAS KIT | Martell Medical Products, Inc. | 1984-07-06 | Traditional | PDF ↗ |
| K841931 | DISPO. AES DISPOS. SYRINGE W/NEEDLE | Hirsch Chemie , Ltd. | 1984-07-06 | Traditional | PDF ↗ |
| K841578 | DISPOSABLE SYRINGE | Ava Medical Products of Canada, Inc. | 1984-05-07 | Traditional | PDF ↗ |
| K840490 | FLUID REMOVAL ASSEMBLY | Ackrad Laboratories | 1984-04-17 | Traditional | PDF ↗ |
| K833706 | CLICK-COUNT U100 INSULIN SYRINGE | Orange Medical Instruments, Inc. | 1984-04-05 | Traditional | PDF ↗ |
| K834256 | PBC SYRINGE IRRIGATING | Philadelphia Biologics Center | 1984-03-23 | Traditional | PDF ↗ |
| K840924 | SYRINGE, PISTON, ARTERIAL BLOOD SAMPL | Medcare Disp Products, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K834548 | HYPODERMIC SYRINGES & NEEDLES | Cordis Corp. | 1984-03-06 | Traditional | PDF ↗ |
| K840192 | PISTON SYRINGE DISPOS. STERILE SYRING | Interexpo Corp. | 1984-03-06 | Traditional | PDF ↗ |
| K834368 | SURGICAL DISPOSABLE STERILE & NONSTERIL | Marbex, Inc. | 1984-03-05 | Traditional | PDF ↗ |
| K840082 | STERILE INSULIN DISPOS. NEEDLE/SYRINGE | Lee Medical Intl., Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K840083 | STERILE INSULIN DISPOS. NEEDLE/GREEN | Lee Medical Intl., Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K833399 | SYRINGE | I M, Inc. | 1984-01-10 | Traditional | PDF ↗ |
| K834165 | SYRINGE | Elfa Trading Co. | 1983-12-13 | Traditional | PDF ↗ |
| K833435 | MULTI PURPOSE SYRINGE | I M, Inc. | 1983-12-12 | Traditional | PDF ↗ |
| K833493 | DISPOSABLE SYRINGES & NEEDLES | Aldrich Chemical Co., Inc. | 1983-11-29 | Traditional | PDF ↗ |
| K833460 | SYRINGE,PISTON NEEDLE, HOLLOW LUMEN | Aldrich Chemical Co., Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K832605 | TRANCOJECT DISPOSABLE SYRINGES | Huborga, Inc. | 1983-11-14 | Traditional | PDF ↗ |
| K832761 | AIR FLUID EXCHANGE PUMP | Intek Int'L, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K832621 | TOP DISPOSABLE PLASTIC SYRINGES | Top Surgical Manufacturers Co. | 1983-10-14 | Traditional | PDF ↗ |
| K832658 | DIRECTOR | Pharmacia, Inc. | 1983-10-04 | Traditional | PDF ↗ |
| K832101 | STERILE DISPOSABLE SYRINGE | Lee Medical Intl., Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K823521 | STERILE HD CVP TRAY | Bill Dude Hospital Disposables, Inc. | 1983-04-08 | Traditional | PDF ↗ |
| K823537 | GLUCOSE REAGENT | Ac Biochemical Laboratories, Inc. | 1983-04-06 | Traditional | PDF ↗ |
| K823527 | SUBCLAVIAN INSERTION KIT | Cunningham Woodland, Inc. | 1983-03-31 | Traditional | PDF ↗ |
| K822774 | 9110 SYRINGE | Cardiac Pacemakers, Inc. | 1982-11-03 | Traditional | PDF ↗ |
| K823056 | THE INGLEFIELD MAGIC RING | The Inglefield Co. | 1982-11-03 | Traditional | PDF ↗ |
| K822159 | ANGIOUROGRAPHY KIT | Mallinckrodt Critical Care | 1982-11-03 | Traditional | PDF ↗ |
| K822928 | DISPOSABLE MICRO-INFUSION SYSTEM | Orange Medical Instruments, Inc. | 1982-10-26 | Traditional | PDF ↗ |
| K822185 | LARYNGEAL SYRINGE | Kelleher Corp. | 1982-10-18 | Traditional | PDF ↗ |
| K822420 | REPLAM HYDROXYAPATATITE | Replam Corp. | 1982-09-28 | Traditional | PDF ↗ |
| K822760 | ARTERIAL LINE KIT | Martell Medical Products, Inc. | 1982-09-28 | Traditional | PDF ↗ |
| K822533 | SYRINGES(3-PARTS SINGLE USE) | Impex Laboratories | 1982-09-17 | Traditional | PDF ↗ |
| K822534 | NEEDLES(HYPODERMIC) | Impex Laboratories | 1982-09-17 | Traditional | PDF ↗ |
| K822532 | SYRINGES(2-PARTS SINGLE USE) | Impex Laboratories | 1982-09-17 | Traditional | PDF ↗ |
| K822238 | DISPOSABLE TAIYANG SYRINGE | S.D. Sunnyland Enterprises, Inc. | 1982-08-25 | Traditional | PDF ↗ |
| K822083 | U-100 INSULIN SYRINGE | Terumo Medical Corp. | 1982-08-16 | Traditional | PDF ↗ |
| K821671 | DISPO. AES. | Hiraoka New York, Inc. | 1982-07-28 | Traditional | PDF ↗ |
| K822029 | MONOJET 520 20CC SYRINGES W/NEEDLES | Sherwood Medical Co. | 1982-07-28 | Traditional | PDF ↗ |
| K821528 | SYRINGE, PISTON | Medcare Disp Products, Inc. | 1982-06-09 | Traditional | PDF ↗ |
| K821537 | HENKE DISPOSABLE SYRINGE | C. B. Dumont Company, Inc. | 1982-05-28 | Traditional | PDF ↗ |
| K821096 | A-LINER | Martell Medical Products, Inc. | 1982-05-14 | Traditional | PDF ↗ |
| K821233 | DISPOSABLE PLASTIC SYRINGE W/NEEDLE | Taiyang Corp. | 1982-05-14 | Traditional | PDF ↗ |
| K820384 | GLASS SYRINGES, DRUG, LUER LOCK | Procedure Products, Inc. | 1982-04-15 | Traditional | PDF ↗ |
| K820716 | MONOJECT 512 SYRINGES W/WO NEEDLES | Sherwood Medical Co. | 1982-04-14 | Traditional | PDF ↗ |
Product code FMF · Class II · General Hospital. Data: openFDA.