meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
38
Latest Decision
1986-03-21

Clearances · page 134 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K860706 IV BAND (INTRAVENOUS CATHETER ASSESORY) T. G. & E. Medical KMK Class I 1986-03-21
K853664 HEPARIN MICRO-INFUSOR Y FRN Class II 1986-03-18
K853450 STERISTORAGE CONTAINER K-Seven Industries, Inc. FMF Class II 1986-03-18
K860290 VIAPIC CENTRAL LINE CATHETER Parke-Davis Co. FOZ Class II 1986-03-18
K860272 SOLUTION ADMINISTRATION SETS Travenol Laboratories, S.A. FPA Class II 1986-03-18
K860084 PRESSURE INFUSOR #1900 Pa Medical Corp. KZD Class I 1986-03-18
K855054 THE WOOD PUMP 'OLE RED' T.C. Retigo, Inc. KZD Class I 1986-03-18
K860468 UNICADDY I & II I.V. CONTAINER CADDY IMS POLE MATE Intl. Medication Systems, Ltd. FOX Class I 1986-03-18
K854318 LIFEPORT AMBULATORY INFUSION PUMP Strato Medical Corp. FRN Class II 1986-03-18
K851243 GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION Cook, Inc. LJS Class II 1986-03-14
K855074 FILTERED VACUUM SAFETY TRAP BOTTLE Boehringer Laboratories KDQ Class II 1986-03-13
K852168 ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY Y FRN Class II 1986-03-12
K855064 SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE Cobe Laboratories, Inc. CAK Class II 1986-03-12
K854964 CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES. Deltec Systems, Inc. FRN Class II 1986-03-07
K860596 SWEET DREEMS SIMULATOR Sweet Dreams, Inc. FMS Class II 1986-03-06
K860263 CASTLE 7538 FLOOR LOADING WASHER Castle Co. LDS Class II 1986-03-05
K854359 LM2000A SURGICAL SUCTION MONITOR Engineering, Inc. KDQ Class II 1986-03-03
K854817 INSTAPURE Teledyne, Inc. FRF Class II 1986-02-28
K855065 PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE Cobe Laboratories, Inc. FPB Class II 1986-02-28
K860502 G.A.S./GRIESHABER AIR SYSTEM Grieshaber & Co. FRN Class II 1986-02-27
K855215 AIR/FLUID EXCHANGE SYSTEM Mira, Inc. FRN Class II 1986-02-27
K855248 BLOOD COLLECTING NEEDLE Churchill Corp. FMI Class II 1986-02-26
K853926 NEOCARE MODEL 800 INFANT RADIANT WARMER Draeger Medical, Inc. FMT Class II 1986-02-26
K854058 PK-AC POWERED PATIENT MANUPULATING DEVICE Mannesmann Demag Corp. FNG Class II 1986-02-25
K854806 RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER Grant Medical Center FPA Class II 1986-02-25
K854965 IN LINE VALVE CATALOG NO. 2000A Rao Medical Devices, Inc. FPA Class II 1986-02-21
K860492 NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE Nordisk Infuser System FRN Class II 1986-02-19
K860120 NURSERY AMBIENT LIGHT METER Rocky Mountain Medical Corp. FMS Class II 1986-02-19
K854877 ACU-SYRINGE W/WO NEEDLES Acuderm, Inc. FMF Class II 1986-02-19
K860066 REFLECTIVE BLANKET O.R. Concepts, Inc. KME Class I 1986-02-19
K854157 PMT ACCUPRESSURE INFUSION SYSTEM 3601 Progress Mankind Technology FRN Class II 1986-02-13
K854428 VASC-EZ Barton-Carey Medical Products Co. DWL Class II 1986-02-13
K860242 JMS INFUSION SET Sturbridge Medical FPA Class II 1986-02-13
K854804 MULTIPLE I.V. SETS C. B. Dumont Company, Inc. FPA Class II 1986-02-12
K860436 IVAC MODEL 2080 ELECTRONIC THERMOMETER Y FLL Class II 1986-02-12
K855000 RATEMINDER III INFUSION DEVICE American Edwards Laboratories LDR Class II 1986-02-12
K854863 FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER Travenol Laboratories, S.A. LDR Class II 1986-02-12
K860113 DOUBLE-JECT TRANSFER NEEDLE Medimix Products, Inc. LHI Class II 1986-02-12
K860434 CHEMO-VENT Intl. Medical Industries LHI Class II 1986-02-12
K854441 STUART GILMAN'S WEIGHT LOSS PLAN Alpha Therapeutic Corp. LDQ 1986-02-10
K854122 PRECIOUS LITE MODEL 4224 E & B Technologies, Inc. LBI Class II 1986-02-07
K854547 MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE Sherwood Medical Co. FMI Class II 1986-02-04
K860201 PARENTERAL ADMINISTRATION SET Migada, Ltd. FPA Class II 1986-02-04
K854549 MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU Sherwood Medical Co. FMI Class II 1986-02-04
K854754 PATIENTMATE TM Trend Medical, Inc. FPA Class II 1986-02-04
K854548 MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES Sherwood Medical Co. FMI Class II 1986-02-04
K854937 CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM Carrom Healthcare, Inc. FNL Class II 1986-02-04
K854832 EVEREST & JENNING SERIES 5000 MODULAR BED Carrom Healthcare, Inc. FNL Class II 1986-02-04
K854867 EVEREST & JENNINGS TRADITION-STANDARD BED L109684& Carrom Healthcare, Inc. FNL Class II 1986-02-04
K854940 TIPS AND PADS, CANE,CRUTCH AND WALKER Healthtech Industries, Inc. FNJ Class I 1986-01-30
K854543 PULSE LAVAGE Tava Surgical Instruments FQH Class II 1986-01-27
K853629 BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO C.R. Bard, Inc. FRN Class II 1986-01-27
K854658 CHURCHILL - HBC VENTED BALL CHECK IV SET Churchill Corp. FPA Class II 1986-01-27
K853317 FORTEC MI-305 & 306 DIGITAL THERMOMETER Nam Tai , Ltd. FLL Class II 1986-01-27
K860071 HOLD-IT FRAMED ADHESIVE FILM Vlv Associates, Inc. KMK Class I 1986-01-27
K854566 TERUMO SURFLO ETFE I.V. CATHETER Terumo Medical Corp. FOZ Class II 1986-01-23
K854574 IVAC CONTROLLED RELEASE INFUSION SYSTEM Y FPA Class II 1986-01-23
K854556 TRANSFER NEEDLE Soma Intl., Inc. LHI Class II 1986-01-16
K853814 MP0400 ADULT, PERISTALIC INFUSION PUMP Medex, Inc. FRN Class II 1986-01-16
K854706 DIGITAL FASHION THERMOMETER Kanada Manufacturing Co., Ltd. FLL Class II 1986-01-16
K854065 INFANT LIFE SUPPORT MODULE-20 Intl. Biomedics, Inc. FPL Class II 1986-01-16
K855131 SUTURE REMOVAL KIT Dynarex Corp. JOK Class I 1986-01-13
K860023 COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT Atrium Medical Corp. KDQ Class II 1986-01-10
K853843 IV MATE Medtech Intl., Inc. FLN Class II 1986-01-09
K854628 CHURCHILL-HCM VENTED IV SET Churchill Corp. FPA Class II 1986-01-09
K851293 IMPLANTOFIX Burron Medical Products, Inc. LJT Class II 1986-01-09
K854446 TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET Terumo Medical Corp. FPA Class II 1986-01-09
K854562 CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I Medelec Intl. Corp. BRZ Class II 1986-01-09
K853348 L-CATH EXPANDO CATH Luther Medical Products, Inc. FOZ Class II 1986-01-09
K854800 NORELCO DIGITAL THERMOMETER, MODEL HT 960 Philips Park FLL Class II 1986-01-09
K854040 I.V. DRESSING Consolidated Medical Equipment, Inc. KMK Class I 1986-01-09
K854259 SEPACELL R-500 & SEPACELL R-500A Advocacy International, Ltd. CAK Class II 1986-01-08
K852527 SATALEC SEPTOSONIC SC 80/SC 120 Spelna, Inc. FLG Class I 1986-01-03
K853031 JECT-AID Autoject Systems, Inc. KZE Class II 1986-01-01
K854634 BARD PARKER THORACIC VENT Bd Becton Dickinson Vacutainer Systems Preanalytic KDQ Class II 1985-12-27
K853981 INFUSAID INFUSE-A-PORT (MODIFIED) Intermedics/Infusaid, Inc. LJT Class II 1985-12-18
K854776 EVEREST & JENNINGS BED MODEL NO. L109564 & L108564 Carrom Healthcare, Inc. FNJ Class I 1985-12-13
K844853 NIFA NON INVASIVE FLUTTER ASSEMBLY Emergency Management Products, Inc. KDQ Class II 1985-12-12
K854627 CHURCHILL-HS SUSPENDED VENTED IV SET Churchill Corp. FPA Class II 1985-12-10
K850754 MEDAJET XL - JET INJECTOR Mada Medical Products, Inc. KZE Class II 1985-12-10
K854629 CHURCHILL-H EXTENSION TUBE Churchill Corp. FPK Class II 1985-12-10
K854073 MODEL 210 INFUSION PUMP Avi, Inc. FRN Class II 1985-12-10
K854155 STERILE SALINE SOLUTION I M, Inc. KMJ Class I 1985-12-10
K854074 MODEL 200 INFUSION PUMP Avi, Inc. FRN Class II 1985-12-10
K854636 CHURCHILL-HE VENTED IV SET Churchill Corp. FPA Class II 1985-12-10
K854630 CHURCHILL-HS SUSPENDED NON-VENTED IV SET Churchill Corp. FPA Class II 1985-12-10
K852645 FLUID MANAGEMENT SYSTEM Haemonetics Corp. FRN Class II 1985-12-09
K854563 DISPOSABLE SYRINGES & NEEDLES Medelec Intl. Corp. FMF Class II 1985-12-09
K854172 I.V. WATCH Alltek, Inc. FPB Class II 1985-12-05
K854435 CHURCHILL-H NON-VENTED IV SET Churchill Corp. FPA Class II 1985-12-05
K854437 CHURCHILL-H VENTED IV SET Churchill Corp. FPA Class II 1985-12-05
K853120 ADDITIVE EXTENSION SYRINGE Abbott Laboratories FMF Class II 1985-12-05
K854436 CHURCHILL-H SCALP VEIN SET Churchill Corp. FPA Class II 1985-12-05
K852825 TMA TEMPERATURE MONITOR Ferguson Medical FLL Class II 1985-12-03
K853881 THE TRAVENOL 5 ML/HR INFUSOR Travenol Laboratories, S.A. FRN Class II 1985-12-02
K854019 PORT-GARD Cormed, Inc., Sub. C.R.Bard, Inc. LJT Class II 1985-11-26
K854006 PLASTELAST AND/OR ELASTOPLASTE Cp Medical KGX Class I 1985-11-25
K844479 CHEMSPOR American Sterilizer Co. FRC Class II 1985-11-25
K853392 MON-A-THERM SUBCUTANEOUS TEMP. SENSOR Mon-A-Therm, Inc. FLL Class II 1985-11-22
K851244 GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO Cook, Inc. KDQ Class II 1985-11-19

15,723 clearances in the General Hospital panel. Data: openFDA.