Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 38
- Latest Decision
- 1990-10-22
Clearances · page 110 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K903590 | KEJUMP DIGITAL CLINICAL THERMOMETER | K-Jump Health Co., Ltd. | FLL | Class II | 1990-10-22 |
| K903703 | PATIENT EXAMINATION GLOVES | P.T. Tulip Indah Agung | LYY | Class I | 1990-10-22 |
| K904642 | VINYL EXAMINATION GLOVES(MFG:KAO YING INDUSTRIAL) | Predex Co. , Ltd. | LYZ | Class I | 1990-10-19 |
| K896813 | MODIFIED INTRAVENOUS CATHETER | Safeguard Needle Co. | FOZ | Class II | 1990-10-19 |
| K902109 | STATLOCK IV CONNECTOR AND ANCHOR SET | Venetec, Inc. | FPA | Class II | 1990-10-19 |
| K904641 | LATEX EXAMINATION GLOVES(MFG: MODLOOK INDUSTRIES) | Predex Co. , Ltd. | LYY | Class I | 1990-10-19 |
| K904077 | VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM | Med Institute, Inc. | LJT | Class II | 1990-10-17 |
| K904382 | SAFE-T-STIK | Xikon Technology | FMF | Class II | 1990-10-17 |
| K904443 | PATIENT EXAMINATION GLOVES | Pisak Enterprise Co., Ltd. | LYY | Class I | 1990-10-17 |
| K904518 | VOLUMETRIC INFUSION PUMP | Kendall Mcgaw Laboratories, Inc. | FRN | Class II | 1990-10-17 |
| K902906 | GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR | Gas-Vak | FLI | Class II | 1990-10-15 |
| K904295 | PROGUARD(TM) BLOOD COLLECTION NEEDLE | Safety-Ject, Inc. | FMI | Class II | 1990-10-15 |
| K904252 | HEATWAVE | Medadvances, Inc. | LGZ | Class II | 1990-10-15 |
| K903378 | MODEL C286 ISOLETTE INFANT INCUBATOR | Air-Shields Vickers, Inc. | FMZ | Class II | 1990-10-15 |
| K904525 | PATIENT EXAMINATION GLOVES | Jian Win Latex Product Factory | LYY | Class I | 1990-10-12 |
| K904511 | HAND-CARRIED STRETCHERS/BREAK AWAY FLAT | Minto Research & Development, Inc. | FPP | Class I | 1990-10-12 |
| K903904 | SERIES 2000 ADJUSTABLE BED | Equi-Tron Mfg., Inc. | FNL | Class II | 1990-10-12 |
| K903691 | A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX. | Therex Corp. | LJT | Class II | 1990-10-12 |
| K904494 | HAND-CARRIED STRETCHERS | Minto Research & Development, Inc. | FPP | Class I | 1990-10-12 |
| K904261 | LITTER, NONRIDGID, POLELESS, NYLON STRETCHER | Dow Cover Co., Inc. | FPP | Class I | 1990-10-12 |
| K904130 | CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL) | Biosafety Systems, Inc. | LYY | Class I | 1990-10-10 |
| K903220 | PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM | Pharmacia Deltec, Inc. | LJT | Class II | 1990-10-10 |
| K903500 | MASCOT THERMOTER | Mascot, Inc. | FLK | Class II | 1990-10-09 |
| K904122 | INSYTE-A ARTERIAL CATHETERIZATION UNIT | Deseret Medical, Inc. | FOZ | Class II | 1990-10-04 |
| K901550 | IVAC(R) SYRINGE PUMP - MODEL 770 | Y | FRN | Class II | 1990-10-04 |
| K901088 | LOW VOLUME BIFURCATED IV EXTENSION SET | Marquette Medical, Inc. | FPA | Class II | 1990-10-04 |
| K900336 | V SET | Go Medical Industries Pty. , Ltd. | FPA | Class II | 1990-10-04 |
| K901089 | LOW VOLUME TRIFURCATED IV EXTENSION SET | Marquette Medical, Inc. | FPA | Class II | 1990-10-04 |
| K904217 | PRO-LOK (TM) EXTENSION SETS | Vlv Associates, Inc. | FPA | Class II | 1990-10-03 |
| K904324 | LATEX EXAMINATION GLOVE | Gallimore Ent., Inc. | LYY | Class I | 1990-10-03 |
| K904011 | MODEL #527 OPHTHALMIC STRETCHER | Midmark Corp. | FPO | Class II | 1990-10-03 |
| K903732 | KENDALL SAFETRAK(TM) HIGH FLOW CATHETER | Kendall Healthcare Products Co. Div.Of Tyco Health | FOZ | Class II | 1990-10-03 |
| K901901 | PROFILE, A CRITICAL CARE LOW AIR LOSS BED | Kinetic Concepts, Inc. | FNM | Class II | 1990-10-03 |
| K903879 | IVAC(R) SYRINGE PUMP - MODEL 740 | Y | FRN | Class II | 1990-10-03 |
| K903809 | PROTECTED NEEDLE WITH OR WITHOUT IV SET | Kendall Mcgaw Laboratories, Inc. | FPA | Class II | 1990-10-03 |
| K904286 | SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED | Scale-Tronix, Inc. | FRW | Class I | 1990-10-01 |
| K904048 | MULTI DRUG INFUSION SYSTEM | I-Flow Corp. | FRN | Class II | 1990-10-01 |
| K902808 | DRIPTROL | Trans-Pacific Healthcare-USA | FLN | Class II | 1990-10-01 |
| K904013 | SPIVE NEEDLE SYSTEM, MODIFICATION | Pascall Medical Corp. | FPA | Class II | 1990-10-01 |
| K903096 | RACK-IT (R) | Vengo Industries, Inc. | FLE | Class II | 1990-10-01 |
| K901162 | STERIMATIC(TM) SAFETY NEEDLE | Sterimatic Worldwide, Ltd. | FMI | Class II | 1990-09-28 |
| K901978 | MULTI-DRUG INFUSION SYSTEM | I-Flow Corp. | FRN | Class II | 1990-09-28 |
| K897086 | PARKER AMBULATORY MEDICATION INFUSION PUMP 2004 | Parker Hannifin Corp. | FRN | Class II | 1990-09-28 |
| K903351 | PROLAX DISPOSABLE LATEX GLOVES (PROCEDURE STERILE) | Prolax Medical Products, Inc. | LYY | Class I | 1990-09-26 |
| K903426 | INSULIN SYRINGE GUIDE | Bay State Anesthesia, Inc. | FMF | Class II | 1990-09-26 |
| K902682 | STICK-GARD STERILE CAP | Integrated Medical Systems, Inc. | LDQ | 1990-09-26 | |
| K902811 | ROUTINE DRESSING TRAY | Orion Life Systems, Inc. | MCY | Class II | 1990-09-25 |
| K903723 | BARRIER FREE CEILING LIFT, MDLS HRS-1/2F,1/4F,1/6F | Barrier Free Lifts, Inc. | FNG | Class II | 1990-09-24 |
| K895024 | PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE | Bio-Plexus, Inc. | FMI | Class II | 1990-09-21 |
| K895543 | WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER | Strato Medical Corp. | LJS | Class II | 1990-09-21 |
| K902330 | E-Z FLO + SET | Prn Services, Inc. | FPA | Class II | 1990-09-21 |
| K904232 | BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC | Boston Medical Corp. | LYY | Class I | 1990-09-21 |
| K903447 | STERILE LATEX EXAMINATION GLOVES | Sime Darby USA | LYY | Class I | 1990-09-19 |
| K901701 | CENTRAL VENOUS ACCESS CATHETER | Cardiopulmonics, Inc. | FOZ | Class II | 1990-09-19 |
| K902432 | AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET | Abbott Laboratories | FRN | Class II | 1990-09-19 |
| K904190 | PATIENT EXAMINATION GLOVES | 1st Med, Inc. | LYY | Class I | 1990-09-19 |
| K902374 | CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM | Pharmacia Deltec, Inc. | FRN | Class II | 1990-09-14 |
| K903541 | SAFETY INJECTION PORT | Du-Call Miller Plastics, Inc. | FPA | Class II | 1990-09-14 |
| K902883 | TISSUE/POLYP TRAP SYSTEM | Triton Technology, Inc. | BYZ | Class II | 1990-09-12 |
| K902527 | SPLIT-SECOND INTRODUCER | Bd Becton Dickinson Vacutainer Systems Preanalytic | FOZ | Class II | 1990-09-12 |
| K901949 | IV SET | Jfv, Inc. | FPA | Class II | 1990-09-12 |
| K896892 | KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET | Kawasumi Laboratories Co., Ltd. | FPA | Class II | 1990-09-12 |
| K902141 | ANOLIFT - PORTABLE & ANOLIFT - GANTRY | Anodyne Corp. | FSA | Class I | 1990-09-12 |
| K903501 | RADIANT TEMPERATUR INDICATOR MODEL 25E | Medical Systems Corp. | FLL | Class II | 1990-09-12 |
| K901509 | TRAUMA SLEEVE | Haz-Med, Inc. | KME | Class I | 1990-09-12 |
| K903073 | LATEX FINGER COTS | Dongkuk Trading Co., Ltd. | LZB | Class I | 1990-09-12 |
| K896896 | KAWASUMI SMALL VEIN INFUSION SET | Kawasumi Laboratories Co., Ltd. | FPA | Class II | 1990-09-12 |
| K896893 | KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE | Kawasumi Laboratories Co., Ltd. | FPA | Class II | 1990-09-12 |
| K896895 | KAWASUMI I.V. ADMINISTRATION SET | Kawasumi Laboratories Co., Ltd. | FPA | Class II | 1990-09-12 |
| K896894 | KAWASUMI BLOOD ADMINISTRATION SET | Kawasumi Laboratories Co., Ltd. | FPA | Class II | 1990-09-12 |
| K895597 | VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER | Vas-Cath, Inc. | FOZ | Class II | 1990-09-12 |
| K903289 | PATIENT EXAMINATION GLOVES | Pacificlink Export Industries Private , Ltd. | LYY | Class I | 1990-09-12 |
| K903024 | BI-O.K. STEAM TEST-PAK | Propper Mfg. Co., Inc. | FRC | Class II | 1990-09-12 |
| K901969 | ALERT BED ALARM SYSTEM | Alertronics, Inc. | KMI | Class I | 1990-09-12 |
| K896068 | TIPSTOP(TM) | Gambro-Hospal, Inc. | KGX | Class I | 1990-09-10 |
| K895764 | MODIFIED LYOFOAM WOUND DRESSINGS | Acme United Corp. | KMF | Class I | 1990-09-10 |
| K895810 | SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE | Shargh Pharmaceutical Co., Inc. | FMF | Class II | 1990-09-07 |
| K903569 | CURITY THORACENTESIS TRAY | Kendall Healthcare Products Co. Div.Of Tyco Health | JOL | Class II | 1990-09-07 |
| K895980 | SHARGHP INSULIN SYRINGES | Shargh Pharmaceutical Co., Inc. | FMF | Class II | 1990-09-07 |
| K895812 | SHARGHP INTRAVENOUS CATHETER | Shargh Pharmaceutical Co., Inc. | FOZ | Class II | 1990-09-07 |
| K895811 | SHARGHP HYPODERMIC NEEDLE | Shargh Pharmaceutical Co., Inc. | FMI | Class II | 1990-09-07 |
| K903717 | DISPENSA-LUBE | Gam-Med Packaging Corp. | KMJ | Class I | 1990-09-06 |
| K902696 | N-DEX | Moss Point Glove Co. | LYY | Class I | 1990-09-05 |
| K903783 | AVI MICRO 275CM INFUSION PUMP | 3M Avi, Inc. | FRN | Class II | 1990-09-05 |
| K902670 | PM GLOVES (MFG: BJL GLOVE (M) SDN.BHD.) | Pm Gloves, Inc. | LYY | Class I | 1990-09-05 |
| K903746 | COMFIT, PATIENT EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | FMC | Class I | 1990-09-05 |
| K903782 | AVI MODEL 270CM INFUSION PUMP | 3M Avi, Inc. | FRN | Class II | 1990-09-05 |
| K902708 | SAFETY FIRST | Bright Rubber Industries Private , Ltd. | LYY | Class I | 1990-09-05 |
| K903785 | AVI MODEL 400CM INFUSION PUMP | 3M Avi, Inc. | FRN | Class II | 1990-09-05 |
| K903786 | AVI MICRO 845 DUAL CHANNEL INFUSION PUMP | 3M Avi, Inc. | FRN | Class II | 1990-09-05 |
| K903787 | AVI MODEL 470CM INFUSION PUMP | 3M Avi, Inc. | FRN | Class II | 1990-09-05 |
| K903756 | STERILE PATIENT EXAMINATION GLOVES | Tillotson Rubber Co., Inc. | LYY | Class I | 1990-09-05 |
| K901419 | DUAL PORT | Infusaid Corp. | LJT | Class II | 1990-09-05 |
| K903788 | AVI MICRO 285CM INFUSION PUMP | 3M Avi, Inc. | FRN | Class II | 1990-09-04 |
| K893060 | MEDI, CURI EXAM GLOVES | Golden Charter , Ltd. | LYY | Class I | 1990-09-04 |
| K900208 | ZEROWET SPLASHIELD | Zerowet Splashield | KYZ | Class I | 1990-09-04 |
| K902464 | CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY | Chartermed, Inc. | KPE | Class II | 1990-08-30 |
| K903789 | AVI MICRO 885 DUAL CHANNEL INFUSION PUMP | 3M Avi, Inc. | FRN | Class II | 1990-08-30 |
| K896134 | ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. | Goosen Enterprises, Inc. | GCX | Class II | 1990-08-30 |
| K901330 | THE MONITOR ELECTRONIC BED ALARM SYSTEM | The Monitor Corp. | KMI | Class I | 1990-08-30 |
15,723 clearances in the General Hospital panel. Data: openFDA.