Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 34
- Latest Decision
- 1997-08-06
Clearances · page 80 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K971948 | PATIENT RESTRAINT | E.M. Adams Co., Inc. | FMQ | Class I | 1997-08-06 |
| K971731 | UNIGLOVES | Uni-Glove (Usa), Inc. | LYY | Class I | 1997-08-05 |
| K970926 | DOUBLE LUMEN PICC | B.Braun Medical, Inc. | LJS | Class II | 1997-08-01 |
| K970669 | AEROQUIP SAFESTART IV CATHETER | Aeroquip Medical Products | FOZ | Class II | 1997-08-01 |
| K970644 | AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM | Aeroquip Medical Products | FOZ | Class II | 1997-07-31 |
| K972153 | ALTERNATING PRESSURE AIR FLOTATION MATTRESS | Decubiti Concepts, Inc. | FNM | Class II | 1997-07-31 |
| K972336 | DERMAMEND HYDROGEL GAUZE DRESSING | Dermarx Corp. | KMF | Class I | 1997-07-29 |
| K972177 | POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | LZA | Class I | 1997-07-29 |
| K972069 | STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK | Stryker Instruments | FQH | Class II | 1997-07-29 |
| K972195 | POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | LZA | Class I | 1997-07-29 |
| K971949 | POWDER-FREE PATIENT EXAMINATION GLOVES | Tekmedic (M) Sdn Bhd | LYY | Class I | 1997-07-28 |
| K971695 | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER | Fisher & Paykel Electronics , Ltd. | FMT | Class II | 1997-07-28 |
| K972291 | ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES | Allegiance Healthcare Corp. | LYY | Class I | 1997-07-28 |
| K972528 | DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) | Dyna Corp. | FPO | Class II | 1997-07-28 |
| K971664 | RAMY PISTON SYRINGE | Alshifa Medical Syringes Mfg. Co., Ltd. | FMF | Class II | 1997-07-25 |
| K972123 | PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 | Smith | FMQ | Class I | 1997-07-25 |
| K972074 | SUCTION INSTRUMENTATION | Walter Lorenz Surgical, Inc. | GCX | Class II | 1997-07-25 |
| K972302 | POCKET COUNT OR SAFETCOUNT | Sage Products, Inc. | LWH | Class I | 1997-07-25 |
| K971742 | DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT | Depuy, Inc. | FMQ | Class I | 1997-07-24 |
| K972452 | RAMY INTEGRATED NEEDLE SYRINGE | Alshifa Medical Syringes Mfg. Co., Ltd. | FMF | Class II | 1997-07-24 |
| K964230 | CORELIFE | Core Healthcare , Ltd. | FMF | Class II | 1997-07-24 |
| K972338 | PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. | Geriatric Products, Inc. | FMQ | Class I | 1997-07-24 |
| K972159 | FENWAL 40 MICRON TRANSFUSION FILTER | Baxter Healthcare Corp | CAK | Class II | 1997-07-23 |
| K954320 | MODIFIED PEDIKAIR | Kinetic Concepts, Inc. | FNM | Class II | 1997-07-18 |
| K970547 | ISOLYSER SDS SHARPS CONTAINER | Thantex Specialties, Inc. | FMI | Class II | 1997-07-18 |
| K963574 | PULSE*SPRAY INJECTOR | AngioDynamics, Inc. | FRN | Class II | 1997-07-18 |
| K971568 | REST MATTRESS | Rest Mattress | FNM | Class II | 1997-07-18 |
| K962159 | STERILE AMBULATORY RESERVOIR 60ML/100ML | Faulding Medical Device Co. | MRZ | Class II | 1997-07-18 |
| K971461 | SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) | Fisher & Paykel Electronics , Ltd. | FMT | Class II | 1997-07-16 |
| K964439 | NEEDLE-FREE VALVED CONNECTOR AND CAP | Bmw Medical, Inc. | FPA | Class II | 1997-07-16 |
| K971168 | ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE | Baxter Healthcare Corp | MEB | Class II | 1997-07-15 |
| K971561 | PROVEST-PROTECTIVE RESTRAINT | Jemm Medical Products | FMQ | Class I | 1997-07-14 |
| K970770 | LATEX EXAMINATION GLOVES | Oon Corp. Resources | LYY | Class I | 1997-07-14 |
| K972259 | PRO CHECK DIGITAL PACIFIER THERMOMETER | Micro Weiss Electronics | FLL | Class II | 1997-07-10 |
| K971546 | SOMA 900 TRANSPORT BED | Nova Technologies, Inc. | FNL | Class II | 1997-07-10 |
| K970011 | ESCORT II CLINICAL THERMOMETRY MODULE (CTM) | Medical Data Electronics | FLL | Class II | 1997-07-09 |
| K971337 | EPITECH ISLAND DRESSINGS | Rynel, Ltd. Inc. | KMF | Class I | 1997-07-09 |
| K970191 | UNIJECT EXAMINATION GLOVES | Uniject Gloves , Ltd. | LYY | Class I | 1997-07-03 |
| K972089 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224 | Alexander Mfg. Co. | MRZ | Class II | 1997-07-03 |
| K971865 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P | Alexander Mfg. Co. | LDR | Class II | 1997-07-03 |
| K971866 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010 | Alexander Mfg. Co. | FLL | Class II | 1997-07-03 |
| K972084 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 | Alexander Mfg. Co. | FLN | Class II | 1997-07-03 |
| K971666 | SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES | Sj Medical Products (M) Sdn Bhd | LZA | Class I | 1997-07-03 |
| K971826 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 | Alexander Mfg. Co. | LDR | Class II | 1997-07-03 |
| K970398 | SHARPS CONTAINER | Custom Medical Plastics, Inc. | FMI | Class II | 1997-07-03 |
| K961044 | NOVIGUARD QUICK DRY | Dr. Novis Smith & Co., Inc. | LRJ | Class I | 1997-07-03 |
| K970383 | SHARPS CONTAINER | Custom Medical Plastics, Inc. | FMI | Class II | 1997-07-03 |
| K965230 | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP | Abbott Mfg., Inc. | FRN | Class II | 1997-07-03 |
| K971536 | RESTRAINTS (VESTS AND JACKETS) | E.M. Adams Co., Inc. | FMQ | Class I | 1997-07-01 |
| K971293 | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE | Abbott Mfg., Inc. | FPA | Class II | 1997-06-27 |
| K971665 | SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES | Sj Medical Products (M) Sdn Bhd | LZA | Class I | 1997-06-27 |
| K970977 | LATEX EXAMINATION GLOVES, POWDER FREE | Arista Medi Prima | LYY | Class I | 1997-06-27 |
| K970269 | CLINICATH IR PERIPHERALLY INSERTED CATHETER | Sims Deltec, Inc. | LJS | Class II | 1997-06-26 |
| K970222 | LOW PROTEIN LATEX EXAMINATION GLOVES | Kossan Latex Industries(M)Sdn Bhd | LYY | Class I | 1997-06-24 |
| K971483 | SECURE-WRAP (TM) STERILIZATION WRAP | American Threshold Industries, Inc. | FRG | Class II | 1997-06-24 |
| K965027 | VENTED I.V. SET | Jms Co., Ltd. | FPA | Class II | 1997-06-24 |
| K970855 | CLAVE CONNECTOR | Icu Medical, Inc. | FPA | Class II | 1997-06-24 |
| K970015 | ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES | Eci Medical Technologies, Inc. | LZA | Class I | 1997-06-24 |
| K970918 | BROWNE STEAM INDICATOR | Board of Directors, Albert Browne , Ltd. | JOJ | Class II | 1997-06-24 |
| K964826 | POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION | Kossan Latex Industries(M)Sdn Bhd | LYY | Class I | 1997-06-24 |
| K970916 | H.V. PULSE LAVAGE (L31 SERIES) | Global Medical Products, Inc. | FQH | Class II | 1997-06-20 |
| K965222 | MICROJECT MODEL PCA-1 | Microject, Inc. | MEB | Class II | 1997-06-19 |
| K964724 | POWDER-FREE LATEX EXAMINATION GLOVES | Pwa Industries Sdn. Bhd. | LYY | Class I | 1997-06-16 |
| K961634 | NIL - POWDER-FREE LATEX EXAMINATION GLOVES | Hl Rubber Products Sdn Bhd | LYY | Class I | 1997-06-16 |
| K964042 | EXTRESAFE PHLEBOTOMY | Specialized Health Products, Inc. | FMI | Class II | 1997-06-06 |
| K963748 | BIO-PLEXUS DROP-IT NEEDLE HOLDER | Bio-Plexus, Inc. | FMI | Class II | 1997-06-06 |
| K971701 | CONTINU-FLO SOLUTION SET | Baxter Healthcare Corp | FPA | Class II | 1997-06-06 |
| K954142 | STERRADD STERILIZATION SYSTEM | Advanced Sterilization Products | FLE | Class II | 1997-06-06 |
| K964067 | GORE IRRIGATION SET | W. L. Gore & Associates, Inc. | FPA | Class II | 1997-06-05 |
| K971424 | DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES | Ansell Perry | LYY | Class I | 1997-06-04 |
| K971066 | TAMARYN I.V. FLOW REGULATOR EXTENSION SET | Tamaryn Medical Systems, Inc. | FPA | Class II | 1997-06-04 |
| K963571 | VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR | Vygon Corp. | FMI | Class II | 1997-06-02 |
| K964929 | PERIPHERALLY INSERTED CENTRAL CATHETER | B.Braun Medical, Inc. | LJS | Class II | 1997-06-02 |
| K971085 | SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER | B.Braun Medical, Inc. | LJS | Class II | 1997-06-02 |
| K970803 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE | Retractable Technologies, Inc. | MEG | Class II | 1997-05-29 |
| K971403 | SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE | Sj Medical Products (M) Sdn Bhd | LYY | Class I | 1997-05-29 |
| K964861 | ACUPUNCTURE NEEDLES | C.A.M. Supply, Inc. | MQX | Class II | 1997-05-29 |
| K971212 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018 | Alexander Mfg. Co. | MRZ | Class II | 1997-05-27 |
| K971213 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P | Alexander Mfg. Co. | MRZ | Class II | 1997-05-27 |
| K971237 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108 | Alexander Mfg. Co. | MRZ | Class II | 1997-05-27 |
| K970786 | ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7) | Alexander Mfg. Co. | MRZ | Class II | 1997-05-27 |
| K971234 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825 | Alexander Mfg. Co. | MRZ | Class II | 1997-05-27 |
| K971423 | VINYL PATIENT EXAMINATION GLOVE, POWDERED | Shanghai Foremost Plastic Industrial Co., Ltd. | LYZ | Class I | 1997-05-23 |
| K971415 | VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE | Shanghai Foremost Plastic Industrial Co., Ltd. | LYZ | Class I | 1997-05-23 |
| K971430 | PROSPORE II | Raven Biological Laboratories, Inc. | FRC | Class II | 1997-05-22 |
| K971432 | PROSPORE | Raven Biological Laboratories, Inc. | FRC | Class II | 1997-05-20 |
| K964605 | BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000) | Thermoscan, Inc. | FLL | Class II | 1997-05-16 |
| K970362 | CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM | Apex Metal, Inc. | FNM | Class II | 1997-05-16 |
| K970428 | REST X SYSTEM | Restxsys | FNM | Class II | 1997-05-14 |
| K970441 | K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH | Medi-Flex Hospital Products, Inc. | FPX | Class I | 1997-05-09 |
| K970600 | DERMAMEND FOAM ISLAND DRESSING | Dermarx Corp. | KMF | Class I | 1997-05-08 |
| K960441 | STERITEC INTEGRAPH MODEL CI-101 | Steritec Products Mfg Co, Inc. | JOJ | Class II | 1997-05-08 |
| K970432 | INFANT RADIANT WARMER - MODELS IW910 AND IW920 | Fisher & Paykel Electronics , Ltd. | FMT | Class II | 1997-05-07 |
| K963622 | VAIL 2000 ENCLOSED BED | Vail Products, Inc. | FNL | Class II | 1997-05-07 |
| K955622 | AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; | Baxter Healthcare Corp | LHI | Class II | 1997-05-06 |
| K970909 | SAFE-CONNECT I.V. SET | Faulding Medical Device Co. | FPA | Class II | 1997-05-06 |
| K970794 | LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) | Siam Sempermed Corp., Ltd. | LYY | Class I | 1997-05-06 |
| K970899 | SAFESKIN POWDERED EXAMINATION GLOVE | Safeskin Corp. | LYY | Class I | 1997-05-06 |
| K964256 | CYGNUS INSTRUMENT PROTECTORS | Madison Polymeric Engineering | FRG | Class II | 1997-05-06 |
| K960738 | STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) | Engineered Custom Mfg., Inc. | KCT | Class II | 1997-05-06 |
15,723 clearances in the General Hospital panel. Data: openFDA.