Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 38
- Latest Decision
- 1982-06-22
Clearances · page 146 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K821624 | LOW VOLUME INFUSTION SET | Lifemed of California | FPA | Class II | 1982-06-22 |
| K821648 | GAS CHEX PLASTIC BAG | Propper Mfg. Co., Inc. | JOJ | Class II | 1982-06-22 |
| K821703 | MGN CONDUCTIVE CONNECTING TUBE, STERILE | Mgn Medical Manufacturing, Inc. | BYY | Class II | 1982-06-22 |
| K821578 | VENOSET DUAL-RATE PIGGYBACK W/IVEX & | Abbott Laboratories | FPA | Class II | 1982-06-22 |
| K821591 | STEAM STERILIZATION EQUIPMENT | Getinge International, Inc. | FLE | Class II | 1982-06-22 |
| K821661 | FLEXIFLO-II | Abbott Laboratories | FRN | Class II | 1982-06-22 |
| K821577 | DESERET ANGIO GUIDE | Warner-Lambert Co. | FOZ | Class II | 1982-06-16 |
| K821405 | MAGUN BASE I.V. POLE | Manuco Manufacturing Co., Inc. | FOX | Class I | 1982-06-16 |
| K821069 | MODEL AS6M INFUSION PUMP | Baxter Healthcare Corp | FRN | Class II | 1982-06-10 |
| K821529 | DISPOSABLE HYPODERMIC NEEDLES | Medcare Disp Products, Inc. | FMI | Class II | 1982-06-09 |
| K821396 | OUT-RITE WASTE DISPOSABLE BAG | Kleen Test Products | LDQ | 1982-06-09 | |
| K821515 | VENTED NITROGLYCERIN I.V. SET | Abbott Laboratories | FPA | Class II | 1982-06-09 |
| K821528 | SYRINGE, PISTON | Medcare Disp Products, Inc. | FMF | Class II | 1982-06-09 |
| K821330 | GAS STERILIZATION POUCHES | Medical Industries Packaging, Inc. | FRG | Class II | 1982-06-07 |
| K821331 | MEDI-SEAL STERILIZATION POUCHES & TUB | Medical Industries Packaging, Inc. | FRG | Class II | 1982-06-07 |
| K821394 | SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER | Kleen Test Products | MMK | Class II | 1982-06-03 |
| K821482 | STERILE HD PAN SET | Hospital Disposables, Inc. | FRG | Class II | 1982-06-02 |
| K821372 | DESERET INTRACATH INTRAVENOUS CATHETER | Warner-Lambert Co. | FOZ | Class II | 1982-06-02 |
| K821490 | SILKAFIX ADHESIVE PLASTER | Selomas, Inc. | KGX | Class I | 1982-06-02 |
| K821371 | DESERET SUBCLAVIAN JUGULAR CATHETER SET | Warner-Lambert Co. | FOZ | Class II | 1982-06-02 |
| K821317 | UNIVERSAL I.V. HOLDER | Georgetown Medical Co. | KMK | Class I | 1982-05-28 |
| K821312 | TEMPTREND TEMPERATURE TREND INDICATOR | Liquid Crystal Products, Inc. | KPD | Class II | 1982-05-28 |
| K821314 | FEVER METER | Steridyne Corp. | KDP | Class II | 1982-05-28 |
| K821530 | SYRINGE IRRIGATING | Medcare Disp Products, Inc. | KYZ | Class I | 1982-05-28 |
| K821537 | HENKE DISPOSABLE SYRINGE | C. B. Dumont Company, Inc. | FMF | Class II | 1982-05-28 |
| K821160 | PNEUMO DRAIN T.M. RECORDER #PD-800 | Sugen Industries, Inc. | GCX | Class II | 1982-05-27 |
| K821436 | ELECTRONIC DIGITAL THERMOMETER | Timex Medical Products Corp. | FLL | Class II | 1982-05-27 |
| K821332 | DUSTCOVERS &/OR STERILITY MAINT. COVERS | Medical Industries Packaging, Inc. | KCT | Class II | 1982-05-27 |
| K821023 | THORACIC DRAINAGE SYSTEM | Howmedica Corp. | GCX | Class II | 1982-05-21 |
| K821342 | METAL BACKED ACETABULAR COMPONENT | Intermedics Orthopedics | JOL | Class II | 1982-05-21 |
| K821043 | STERILE PATIENT EXAM. GLOVES | Phoenix Glove Co. | FMC | Class I | 1982-05-21 |
| K821177 | BITE STICK | Abco Dealers, Inc. | FMA | Class I | 1982-05-21 |
| K821257 | SELOFIX | Selomas, Inc. | KGX | Class I | 1982-05-14 |
| K820759 | VEIN-SHIELD | Pan-Tech Research, Inc. | KMK | Class I | 1982-05-14 |
| K821096 | A-LINER | Martell Medical Products, Inc. | FMF | Class II | 1982-05-14 |
| K821228 | DEKNATEL SKIN STAPLE EXTRACTOR | Howmedica Corp. | GAG | Class II | 1982-05-14 |
| K821244 | DISPOSABLE TEMPERATURE PROBE | Shiley, Inc. | FLL | Class II | 1982-05-14 |
| K821233 | DISPOSABLE PLASTIC SYRINGE W/NEEDLE | Taiyang Corp. | FMF | Class II | 1982-05-14 |
| K820994 | ABSORB FURN SHEET | American Convertors Div., American Pharmaseal | FPY | Class I | 1982-05-13 |
| K821148 | ETHOX FOOD PUMP STAND W/POLE CLAMP | Ethox Corp. | FRN | Class II | 1982-05-05 |
| K821047 | IVAC 630 & VOLUMETRIC INFUSION PUMP | Y | FRN | Class II | 1982-05-03 |
| K821032 | MODEL SR-1020LF | Stewart-Riess Labs | FPA | Class II | 1982-05-03 |
| K820024 | DIGITAL CLINICAL THERMOMETER | Faith & Firsts Enterprises Co., Ltd. | FLL | Class II | 1982-04-29 |
| K820946 | AS 70 VOLUMETRIC INFUSION PUMP | Narco Scientific | FRN | Class II | 1982-04-29 |
| K820937 | ACKRAD FLUID CONNECTING SET | Ackrad Laboratories | LHI | Class II | 1982-04-26 |
| K821028 | FINGER COTS | Abco Dealers, Inc. | FMC | Class I | 1982-04-26 |
| K820661 | MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG | Micro-Aire Surgical Instruments, Inc. | FQH | Class II | 1982-04-21 |
| K820860 | VOLUMETRIC PUMP CASSETTE W/ATTACHED SET | Travenol Laboratories, S.A. | FRN | Class II | 1982-04-21 |
| K820963 | PATIENT PAL I.V. WALKER | Pryor Products | FOX | Class I | 1982-04-21 |
| K820159 | PRESSURE INFUSER | David Clark Company, Inc. | KZD | Class I | 1982-04-21 |
| K820962 | COTTON SWABS | Dafoe & Dafoe, Inc. | KXF | Class I | 1982-04-20 |
| K820747 | MONOJECT SAF-T-LOCK | Sherwood Medical Co. | FPA | Class II | 1982-04-15 |
| K820765 | PLEURAL DRAINAGE RESERVOIR | Innovative Surgical Products, Inc. | GCX | Class II | 1982-04-15 |
| K820911 | PBC NEEDLE BY NIPRO MED. INDUSTRIES | Philadelphia Biologics Center | FMI | Class II | 1982-04-15 |
| K820764 | IVAC MODEL 160 AIR-IN-LINE SENSOR | Y | FRN | Class II | 1982-04-15 |
| K820384 | GLASS SYRINGES, DRUG, LUER LOCK | Procedure Products, Inc. | FMF | Class II | 1982-04-15 |
| K820783 | CASTLE MICROCOMPUTER STERILIZER CONTROL | Sybron Corp. | FLF | Class II | 1982-04-15 |
| K820726 | ACCUSET (R) CASSETTE | Imed Ireland, Ltd. | FRN | Class II | 1982-04-14 |
| K820872 | CURITY SHETHOSCOPE SECURING PADS | The Kendal Co. | KGX | Class I | 1982-04-14 |
| K813157 | COLORLESS DISPOSIBLE PLASTIC SYRINGES | Sam Joo Industrial Co., Ltd. | FMF | Class II | 1982-04-14 |
| K820718 | ARGYLE THORACIC CATHETERS | Sherwood Medical Co. | JOL | Class II | 1982-04-14 |
| K820716 | MONOJECT 512 SYRINGES W/WO NEEDLES | Sherwood Medical Co. | FMF | Class II | 1982-04-14 |
| K820689 | C.S.R. WRAPPERS | General Medical Co. | FRG | Class II | 1982-04-09 |
| K820670 | HS17/HS18 SERIES MONITORS | Medtel Pty. , Ltd. | FLL | Class II | 1982-04-09 |
| K820589 | ECONOMY LINE OF TRAYS | Abco Dealers, Inc. | FRG | Class II | 1982-04-09 |
| K820706 | WATERLESS SEAL & VACUUM REGULATOR | Sorensen Research | KDP | Class II | 1982-04-09 |
| K820788 | CLIRANS PRIMING SET | Terumo Medical Corp. | FPA | Class II | 1982-04-06 |
| K820133 | MCGAW FAT EMULSION SET | American Mcgaw | FPA | Class II | 1982-04-06 |
| K820062 | DISPOSABLE PLASTIC SYRINGE & NEEDLE | Marshall Davis, Inc. | FMF | Class II | 1982-04-01 |
| K820371 | PLASTIC CONNECTORS | American Pharmaseal Div. Ahsc | BYY | Class II | 1982-04-01 |
| K820412 | AM. PH. STERILE PLASTIC CONNECTING TUBES | American Pharmaseal Div. Ahsc | BYY | Class II | 1982-03-31 |
| K820482 | ACCU-RYNGE INSULIN PUMP #SP-250 | Delta Medical Industries | FRN | Class II | 1982-03-26 |
| K820587 | WET PACK LINE OF PRODUCTS | Abco Dealers, Inc. | KMJ | Class I | 1982-03-26 |
| K813459 | REUSABLE & DISPOSABLE TEMP. PROBES | Electromedics, Inc. | FLL | Class II | 1982-03-26 |
| K813256 | HYPODERMIC & SUTURE NEEDLES | Needle Industries(Usa), Inc. | FMI | Class II | 1982-03-25 |
| K820584 | DECUBICARE PADS & ACCESSORIES | Abco Dealers, Inc. | FMP | Class I | 1982-03-25 |
| K820294 | BOSTON SYRINGE | Frisco Products, Inc. | FMF | Class II | 1982-03-23 |
| K820521 | STERILIZATION WRAP | General Medical Co. | FRG | Class II | 1982-03-18 |
| K820527 | ANESTHESIA EXTENSION TUBES | David Simmonds Co., Inc. | FPK | Class II | 1982-03-18 |
| K820582 | 3M THINSULATE DISPOSABLE HOSPITAL BED | 3M Company | KME | Class I | 1982-03-18 |
| K820484 | VENES CUSTON RX | Jung Products, Inc. | FQL | Class I | 1982-03-18 |
| K820200 | IV ALERT SYSTEM | Allied Medical Technologies, Inc. | KPE | Class II | 1982-03-18 |
| K820490 | IV START TRAY | Seamless Hospital Products Co. | LRS | Class II | 1982-03-16 |
| K813374 | NUTRICATH | Exco, Inc. | FOZ | Class II | 1982-03-15 |
| K820449 | PHARMACEUTICALS MOD. 1CC-1,2,3 THRU 50CC | Abek Corp. | FMF | Class II | 1982-03-12 |
| K820424 | IMPACT, MODEL 310 | Impact Instrumentation, Inc. | GCX | Class II | 1982-03-12 |
| K820460 | 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION | Superior Plastic Products Corp. | JOL | Class II | 1982-03-08 |
| K820453 | THE INT-STOPPER | Burron Medical Products, Inc. | FPA | Class II | 1982-03-08 |
| K820435 | BAXA ADDISEAL | Baxa Corp., Sub. of Cook Group, Inc. | KPE | Class II | 1982-03-08 |
| K820454 | THE RED CAP | Burron Medical Products, Inc. | FMF | Class II | 1982-03-08 |
| K820426 | TEMPERATURE TREND INDICATOR (TTI) | Mon-A-Therm, Inc. | KPD | Class II | 1982-03-08 |
| K813199 | SKIN TEMPERATURE SENSING VINYL STRIP | T. G. & E. Medical | KPD | Class II | 1982-03-05 |
| K820409 | ELECTRONIC CLINICAL THERMOMETER TEMP PR | Y | FLL | Class II | 1982-03-02 |
| K820337 | IMPACT, MODEL 303 | Impact Instrumentation, Inc. | GCX | Class II | 1982-03-02 |
| K820171 | SUBCLAVIAN INSERTION KIT | Clinipad Corp. | FRG | Class II | 1982-03-02 |
| K812320 | AIR ALIVE | Western Systems, Inc. | FRF | Class II | 1982-02-24 |
| K820164 | EMPTY STERILE CARPUJECT | Sterling Drug, Inc. | FMF | Class II | 1982-02-24 |
| K820302 | SURGIPEEL SELF-SEAL PACKAGING SYSTEM | Surgicot, Inc. | FRG | Class II | 1982-02-24 |
| K813566 | CARDIO-BAND | Cardio-Band, Inc. | LDQ | 1982-02-22 | |
| K813644 | MODEL 2650 HIGH CAPACITY DUAL SYRINGE | Harvard Apparatus, Inc. | FRN | Class II | 1982-02-18 |
15,723 clearances in the General Hospital panel. Data: openFDA.