Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 52
- Latest Decision
- 1980-01-28
Clearances · page 152 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K800080 | STERILIZING CASE CAT. NO. 65199 | Edward Weck, Inc. | FLE | Class II | 1980-01-28 |
| K792136 | HYPO-ALLERGENIC PLASTIC TAPE | National Patent Development Corp. | FPX | Class I | 1980-01-16 |
| K792667 | LEUKOCLIP POROS | Beiersdorf, Inc. | FPX | Class I | 1980-01-16 |
| K792625 | STERILIZATION PROCESS/PLACENTA BASIN | Procter & Gamble Mfg. Co. | FNY | Class I | 1980-01-16 |
| K792124 | TANDEM ASSEMBLED 3&4 WAY STOPCOCKS | Tronomed, Inc. | FMG | Class II | 1980-01-16 |
| K792125 | 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE | Tronomed, Inc. | FMG | Class II | 1980-01-16 |
| K792426 | DISPOSABLE TEMPERATURE PROBE | Hospitak, Inc. | FLK | Class II | 1980-01-16 |
| K792626 | STERILIZATION PROCESS/BABY BLANKET | Procter & Gamble Mfg. Co. | KME | Class I | 1980-01-16 |
| K792228 | VENTED I.V. SET | Abbott Laboratories | FPA | Class II | 1980-01-16 |
| K792126 | 3&4 WAY PLASTIC STERILE STPCKS. PKG. | Tronomed, Inc. | FMG | Class II | 1980-01-16 |
| K792128 | STERILE EXTENSION TUBES INDIV. PKG. | Tronomed, Inc. | FMG | Class II | 1980-01-16 |
| K792127 | PLAS. STCK. W/EXTENSION TUBE/STERILE | Tronomed, Inc. | FMG | Class II | 1980-01-16 |
| K792666 | LEUKOPOR | Beiersdorf, Inc. | KGX | Class I | 1980-01-16 |
| K792116 | YSI SERIES 500 THERMISTOR PROBES | Yellow Springs Instrument Co., Inc. | FLL | Class II | 1980-01-16 |
| K792629 | STERILIZATION PROCESS/T-BINDER | Procter & Gamble Mfg. Co. | KMO | Class I | 1980-01-11 |
| K792624 | STERILIZATION PROCESS/ MAYO PAD | Procter & Gamble Mfg. Co. | JOJ | Class II | 1980-01-11 |
| K792570 | PATIENT TROLLEY B49 | Ets Rene Marzet | FPO | Class II | 1979-12-31 |
| K792360 | HANSAPOR STERILE | Beiersdorf, Inc. | FPX | Class I | 1979-12-31 |
| K792601 | LIFELIFT MODELS ONE AND TWO | Corda Int'L Holiday, Inc. | FSA | Class I | 1979-12-31 |
| K792558 | CONTAINER SYSTEM | Aesculap Instruments Corp. | FLE | Class II | 1979-12-27 |
| K792298 | THE VERSA-BED | First & Ten, Inc. | FNJ | Class I | 1979-12-20 |
| K792227 | MULTI-AD FLUID DISPENSING SYSTEM | National Patent Development Corp. | KYX | Class I | 1979-12-20 |
| K792560 | MASTER I.V. DIAL LOCK | The Master Medical Corp. | FPA | Class II | 1979-12-20 |
| K792297 | SPAN AIDS KIT | American Hospital Supply Corp. | FMP | Class I | 1979-12-20 |
| K792510 | MICROBAR MONITORING LINE FILTER | Medex, Inc. | FPB | Class II | 1979-12-20 |
| K792318 | SKIL-CARE TURN AND HOLD PAD | Skil-Care Corp. | FMR | Class I | 1979-12-20 |
| K792566 | THE ARALUEN CARRIER | Araluen, Inc. | FPP | Class I | 1979-12-20 |
| K792538 | CONTINU-FLO ADMIN. SET CODE 2C/200 | Travenol Laboratories, S.A. | FPA | Class II | 1979-12-20 |
| K792295 | SORBIES | American Hospital Supply Corp. | FRL | Class I | 1979-12-20 |
| K792331 | TOMMY TOES | Tommy Toes | FQM | Class I | 1979-12-20 |
| K792432 | TEMPORARY BURN SHEET WITH PERFORATED | American Medical Disposable, Inc. | FPY | Class I | 1979-12-20 |
| K792433 | TEMPORARY BURN SHEET WITH PERFORATED | American Medical Disposable, Inc. | FPY | Class I | 1979-12-20 |
| K792294 | BREAST PAD | American Hospital Supply Corp. | FRL | Class I | 1979-12-11 |
| K792369 | HYPERALIMENTATION DRESSING TRAY | Pharmaseal Div., Baxter Healthcare Corp. | FRG | Class II | 1979-12-10 |
| K792257 | TEMPERATURE MONITOR (W/PROBE) | Biotronex Laboratory, Inc. | FLL | Class II | 1979-12-04 |
| K792142 | MODEL IV 6500 FORMULATOR | Valleylab, Inc. | FRN | Class II | 1979-11-29 |
| K792049 | I.V. STRIP | E-Med Corp. | KMK | Class I | 1979-11-20 |
| K792065 | POROUS ELASTIC RUBBER BANDAGE | Norman R. Sanborn Co. | FQM | Class I | 1979-11-20 |
| K792102 | HYPO-ALLERGENIC CLOTH ADHESIVE TAPE | National Patent Development Corp. | KGX | Class I | 1979-11-16 |
| K792103 | HYPO-ALLERGENIC PAPER ADHESIVE TAPE | National Patent Development Corp. | KGX | Class I | 1979-11-16 |
| K791970 | HYGENIC RUBBER DAM LUBRICANT | The Hygenic Corp. | KMJ | Class I | 1979-11-16 |
| K791865 | HYDRON BURN DRESSING FIELD KIT | National Patent Development Corp. | KMF | Class I | 1979-11-16 |
| K792096 | 2 FR KELMAN CHAMBER MAINTAINER | Heyer Schulte Corp. | FMI | Class II | 1979-11-16 |
| K792033 | DYNACOR STERILE BLOOD GAS SPECIMEN TRAY | Medline Industries, Inc. | FMF | Class II | 1979-11-16 |
| K791293 | BATTERY POWERED SYRINGE INFUSION PUMP | Harvard Apparatus, Inc. | FRN | Class II | 1979-11-13 |
| K791822 | BIOGUARD INFUSION LINE FILTER | United States Surgical, A Division of Tyco Healthc | FPB | Class II | 1979-11-13 |
| K791566 | MODEL AS* 6C INFUSION PUMP | Baxter Healthcare Corp | FRW | Class I | 1979-11-13 |
| K791720 | AR/MDE INFUSOR MODEL 60/2 INFUSION PUMP | Alza Corp. | FRN | Class II | 1979-11-05 |
| K792001 | COMFICARE PAD (FOR SINGEL PT USE) | Hamilton Industries, Inc. | FNM | Class II | 1979-10-26 |
| K792016 | DISCARD-A-PAD 40-COUNT SHARPS DISPOSAL | Arbrook Mfg. Corp. | MMK | Class II | 1979-10-26 |
| K791672 | ALBUMIN INTRAVENOUS ADMINISTRATION SET | Delmed, Inc. | FPA | Class II | 1979-10-26 |
| K791998 | 60CC IRRIGATING SYRINGE, PISTON TYPE, | Waz Industries, Inc. | KYZ | Class I | 1979-10-26 |
| K791930 | IV EXTENSION SET SL | Abbott Laboratories | FPA | Class II | 1979-10-26 |
| K792021 | LARGE VOLUME 5 MICRON CONICAL FILTER | National Patent Development Corp. | FPB | Class II | 1979-10-26 |
| K791774 | LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN | Abbott Laboratories | KPE | Class II | 1979-10-26 |
| K791993 | SKIL-CARE BED RAIL PADS | Skil-Care Corp. | FNJ | Class I | 1979-10-26 |
| K791886 | I.V. CARE KIT | Ascep, Inc. | KGX | Class I | 1979-10-26 |
| K792012 | SKIL-CARE SUPER-SOFT LIMB RESTRAINTS | Skil-Care Corp. | FMQ | Class I | 1979-10-26 |
| K791809 | BLOOD TRANSFUSION MICROFILTER | Pioneer Viggo, Inc. | FPB | Class II | 1979-10-26 |
| K791885 | I.V. START SET | Ascep, Inc. | KGX | Class I | 1979-10-22 |
| K791513 | ADAMCO DUST COVER | Chase Mfg. Co. | FRG | Class II | 1979-10-11 |
| K791847 | ASPRI-LUKE | Medical Marketing Group | BYZ | Class II | 1979-10-02 |
| K791738 | CUSTOM DRESSING CHANGE TRAYS | Sterile Design, Inc. | FMC | Class I | 1979-10-02 |
| K791529 | INFUSION NEEDLE SET | I.M.P. Group , Ltd. | FPA | Class II | 1979-10-02 |
| K791918 | JELCO WINGED INTRAVASCULAR CATHETER | Jelco Laboratories | FOZ | Class II | 1979-10-02 |
| K791796 | ADDITIVE HINGE CAP | Abbott Laboratories | KPE | Class II | 1979-10-01 |
| K791729 | SYRINGE INFUSION PUMP | Princeton Medical Instruments, Inc. | FRN | Class II | 1979-10-01 |
| K791805 | CONPHAR EXAM. GLOVES, POLYETHYLENE | Conphar, Inc. | FMC | Class I | 1979-10-01 |
| K791646 | PLASTIC SHOWER GUARD | B & F Medical Products, Inc. | KIA | Class I | 1979-10-01 |
| K791709 | HEEL/ELBOW PROTECTORS | Fibre Formations, Inc. | FMP | Class I | 1979-09-24 |
| K790948 | TEMP-GUARD TM | Gordon Consultants, Inc. | FMT | Class II | 1979-09-24 |
| K791462 | HYPERDERMIC NEEDLE WITH SENSOR #514 | Medtech Intl., Inc. | FMI | Class II | 1979-09-24 |
| K791801 | CONPHAR FINGERTIP SUCTION CONTROL | Conphar, Inc. | JOL | Class II | 1979-09-21 |
| K791371 | MODEL F-1010 DIGITAL THERMOMETER | Filac Corp. | FLL | Class II | 1979-09-17 |
| K791528 | FLEXIFO ENTERAL NUTRITION PUMP | Abbott Laboratories | FRN | Class II | 1979-09-12 |
| K791660 | PREPACELL-BONE MARROW SAMPLER | Applied Medical Devices, Inc. | FMF | Class II | 1979-09-12 |
| K791558 | TEMP-STIK MODEL #300 | Temp-Stik Corp. | FLL | Class II | 1979-09-12 |
| K791574 | MODIFIED TEMPA-DOT THERMOMETER | Info-Chem | FQZ | Class I | 1979-09-12 |
| K791323 | TECHNION ELECTRONIC FEVER THERMOMETER | Technicon Corp. | FLL | Class II | 1979-09-07 |
| K791114 | BILI-DOSIMETER | Olympic Medical Corp. | LBI | Class II | 1979-09-04 |
| K791412 | DISPOSABLE INSTRUMENT TRAY PAD | Anago, Inc. | KCT | Class II | 1979-08-16 |
| K791288 | YELLOW ALERT SYSTEM | Hemoy, Inc. | KGX | Class I | 1979-08-03 |
| K791345 | MEDICINE CUP | General Clinical Plastics Corp. | KYW | Class I | 1979-08-03 |
| K791208 | IVAC 833 ELECTRONIC THERMOMETER | Y | FLL | Class II | 1979-08-03 |
| K791211 | BINDAFIX | Conphar, Inc. | FQM | Class I | 1979-08-03 |
| K791243 | LUBRICATING JELLY | Abco Dealers, Inc. | KMJ | Class I | 1979-08-03 |
| K791254 | CONPHAR SILICONE DRAINS-STERILE | Conphar, Inc. | KDQ | Class II | 1979-08-03 |
| K791256 | SECUTEX SURGICAL BINDER | Conphar, Inc. | FQM | Class I | 1979-08-03 |
| K791167 | DEXIDE DISPOSABLE PREP PAD | Dexide, Inc. | FRL | Class I | 1979-08-03 |
| K791209 | IVAC 819 ELECTRONIC THERMOMETER | Y | FLL | Class II | 1979-08-03 |
| K791346 | DISPOSABLE BEDPAN | General Clinical Plastics Corp. | FOB | Class I | 1979-08-03 |
| K791156 | AMIPAQUE MYELOGRAM TRAY | Pharmaseal Div., Baxter Healthcare Corp. | FMI | Class II | 1979-07-30 |
| K790811 | EXETER BONE LAUAGE SYSTEM | Howmedica Corp. | FQH | Class II | 1979-07-30 |
| K791168 | DEXIDE DISPOSABLE PREP STICK | Dexide, Inc. | KXF | Class I | 1979-07-30 |
| K791176 | 3M COLD/HOT WATER BAG AND WRAP | 3M Company | FPF | Class I | 1979-07-30 |
| K791173 | SURFLO INJECTION PLUG | Terumo America, Inc. | FPA | Class II | 1979-07-30 |
| K790836 | GUARDIAN II I.V. CONTROLLER | Centaur Sciences, Inc. | FLN | Class II | 1979-07-30 |
| K791169 | DEXIDE DISPOSABLE SWAB STICK | Dexide, Inc. | KXF | Class I | 1979-07-30 |
| K791189 | ECHO CARDIOGRAM PAD | Alimed, Inc. | FNJ | Class I | 1979-07-17 |
| K790657 | STRETCHER TRANSIT ISOLATER #122 | Vickers America Medical Corp. | LGM | Class II | 1979-07-03 |
15,723 clearances in the General Hospital panel. Data: openFDA.