meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
41
Latest Decision
1995-03-13

Clearances · page 92 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K950302 E-Z SET(R) AND MINICATH(R) INFUSION SETS Becton Dickinson Vascular Access, Inc. FPA Class II 1995-03-13
K944660 ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY Neostar Medical Technologies, Inc. FOZ Class II 1995-03-13
K943206 VARIOUS TUBING Prn Services, Inc. FPK Class II 1995-03-09
K935145 CYPERFLO PERIPHERALLY INSERTED CATHETER Cyex Medical Technologies, Inc. LJS Class II 1995-03-09
K945964 KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS Sherwood Medical Co. LZH Class II 1995-03-07
K943563 COMFIT BLUE POWDER FREE EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-03-07
K945250 TRIMPORT Gerard Medical Enterprises, Inc. LJT Class II 1995-03-07
K946010 KAO YING Kao Ying Industrial Co., Ltd. LYZ Class I 1995-03-07
K933848 PRESPO 7, SELF-SUFFICIENT DRIP DEVICE Bonding Corp. FPA Class II 1995-03-03
K943771 MEDX REUSABLE SHARPS CONTAINER Bfi- Medical Waste Systems FMI Class II 1995-03-03
K945767 POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES Ansell, Inc. LYY Class I 1995-03-02
K942378 POCKET PUMP Baxa Infusion Systems FRN Class II 1995-03-01
K945715 MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES Sherwood Medical Co. FMF Class II 1995-03-01
K941557 DISPOSABLE LATEX EXAM GLOVES Dah Lee Investments, Ltd. LYY Class I 1995-02-28
K942905 DISPOSABLE TEMPERATURE PROBE COVER Arbo Medical, Inc. FMT Class II 1995-02-27
K945802 DERMAGRAN WOUND CLEANSER WITH ZINC Derma Sciences, Inc. KMF Class I 1995-02-27
K943162 LAKE STAGEZERO(TM) AIR FLOTATION BED Lake Medical Products, Inc. FNM Class II 1995-02-27
K946203 JAI POWDERFREE LATEX EXAMINATION GLOVES Intl. Trade Management Co. LYY Class I 1995-02-27
K944969 STERI-LUB LUBRICATION GEL Horizon Medical, Inc. KMJ Class I 1995-02-27
K943773 STERILE WATER Medline Industries, Inc. JOL Class II 1995-02-27
K936295 COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC) Wembley Rubber Products LYY Class I 1995-02-24
K943451 ULTIMAX POWDER FREE EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-02-24
K943362 PACIFIER-THERMOMETER Questech Intl., Inc. FLL Class II 1995-02-21
K943310 MODEL 6100 AMBULATORY INFUSION SYSTEM Pharmacia Deltec, Inc. MEA Class II 1995-02-21
K943869 ULTIMAX (GREEN POWDER FREE EXAMINATION) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-02-21
K935380 VASCULAR ACCESS CATHETER ACCESSORIES Bard Access Systems, Inc. LJS Class II 1995-02-17
K942446 I.V. ROLLER GUARD CLAMP Plastic Manufacturing and Marketing Group, Inc. FPA Class II 1995-02-17
K941628 40 MICRON BLOOD TRANSFUSION FILTER Douglas Medical Products Corp. FPB Class II 1995-02-16
K945664 BARIKARE PLUS Kinetic Concepts, Inc. FNL Class II 1995-02-16
K944320 VENTED/NON-VENTED GEMINI ADMINISTRATION SET Imed Corp. FPA Class II 1995-02-14
K944665 DIB INFUSORS Novacon Corp. MEB Class II 1995-02-14
K946291 ELASTYREN(R) PATIENT EXAMINATION GLOVES Eci Medical Technologies, Inc. LZA Class I 1995-02-14
K943521 VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE Schiff & Co. FRA Class II 1995-02-14
K945617 PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS Pharma-Plast Intl. A/S FPA Class II 1995-02-13
K945588 DISPOSABLE 1CC SYRINGE WITH LUER LOCK Interventional Therapeutics Corp. FMF Class II 1995-02-10
K950051 BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B The Brewer Co. FMS Class II 1995-02-10
K950058 MC HEALTHCARE #CH31 CHILD'S CRIB Janco Consulting Services FMS Class II 1995-02-10
K950059 MC INFANT CARE UNIE #PP30 Janco Consulting Services FMS Class II 1995-02-10
K943897 NU-SITE Medex, Inc. FPA Class II 1995-02-10
K945330 ALLEVYN ADHESIVE Smith & Nephew United, Inc. KMF Class I 1995-02-09
K944733 PLUM XL INFUSION PUMP Abbott Laboratories FRN Class II 1995-02-08
K942349 MICROBORE EXTENSION SET Excelsior Medical Corp. FPA Class II 1995-02-08
K945184 INTRAVASCULAR ADMINISTRATION SET Distronic Sterile Products, Inc. FPK Class II 1995-02-08
K945499 CATO FIRST PICC KIT Catco Medical, Inc. LJS Class II 1995-02-07
K946101 EMERGENCY/ACCIDENT TROLLEY 550 Hogan & Hartson FPO Class II 1995-02-07
K940657 IV BAG PUMP I-Flow Corp. FPA Class II 1995-02-03
K942511 SCIPOTEX POWDER FREE EXAM GLOVES (BEADED) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-02-03
K943868 SCIPOTEX Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-02-03
K945164 MULTIPLE Protection Gloves Sdn. Bhd. LYY Class I 1995-02-03
K942848 STRATO MEDICAL LIFEPORT LPS 7515 Strato Medical Corp. LJT Class II 1995-02-01
K940555 SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION Sandoz Nutrition LZH Class II 1995-02-01
K940635 SAFE-1(TM) SYRINGE Safety 1st Medical, Inc. FMF Class II 1995-01-31
K944680 SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE Researched, Novel Medical Devices (Rn/Md) FMI Class II 1995-01-31
K941190 CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET Icu Medical, Inc. FPA Class II 1995-01-31
K943653 MAMMOCORE BIOPSY TRAY Manan Medical Products, Inc. FRG Class II 1995-01-30
K934518 STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM Strato Medical Corp. LJT Class II 1995-01-27
K942394 SAFE VENT SYSTEM Incutech, Inc. FMF Class II 1995-01-27
K944121 SHARPS CONTAINER 18 GALLON Bci, Inc. FMI Class II 1995-01-27
K944183 TRU-TOUCH MEDICAL GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic LYZ Class I 1995-01-26
K944425 ULTRASAFE ASPIRATING SYRINGE Safety Syringes, Inc. MEG Class II 1995-01-26
K941031 TOHP-CAP Jrm Ent., Inc. FMI Class II 1995-01-26
K945225 DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES Myco Medical Supplies, Inc. FMF Class II 1995-01-26
K944619 I.V.I.D. FLUID ADMINISTRATION SET MARKER Advanced Bioresearch Assoc. FPA Class II 1995-01-26
K946027 BIG PHIL Biomedical Waste Systems, Inc. FMI Class II 1995-01-26
K943969 MODEL 578 MOBILE SURGICAL STRETCHER Hausted, Inc. FPO Class II 1995-01-25
K945431 MODEL 792 CONVERGE, MODEL 793 VISION 2000 Hausted, Inc. FPO Class II 1995-01-25
K942948 STRYKER POWERED STRETCHER Stryker Corp. FPO Class II 1995-01-24
K935811 BOLUS DISPENSER I-Flow Corp. FPA Class II 1995-01-20
K941083 DYNAMEDICS ASAR Dynamedics Corporation FNM Class II 1995-01-20
K945473 V-CATH BREAKAWAY NEEDLE INTRODUCER Hdc Corp. KZH Class II 1995-01-20
K943017 NEONATAL RESTRAINT AND COMFORT SYSTEMS K.Bowmed, Inc. FRP Class I 1995-01-19
K946155 LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE) Mala Intertrade Co., Ltd. LYY Class I 1995-01-17
K945070 VERSASAE PLASTIC CANNULA- 11 GAUGE Imed Corp. FPA Class II 1995-01-13
K945144 SPONGE COUNT Michael Fischer Assoc. LWH Class I 1995-01-12
K946321 BIOSTRIP STERILE WOUND CLOSURE STRIP Cornelia Damsky, Inc. FPX Class I 1995-01-12
K945206 ALLDRESS MULTI LAYERED WOUND DRESSING Scott Health Care KMF Class I 1995-01-12
K946269 CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS Kendall Healthcare Products Co. Div.Of Tyco Health KMF Class I 1995-01-12
K945978 TUBING, NONINVASIVE Endoscopic Technologies, Inc. GAZ Class II 1995-01-11
K945031 ROYALSHIELD NON-STERILE POWDER-FREE Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1995-01-11
K946154 MALA LATEX EXAM GLOVES AND SCAN-SUB Lowenkamp Intl., Inc. LYY Class I 1995-01-11
K944757 PISTON SYRINGES Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1995-01-11
K942045 INSYTE INTRODUCER CATHETER Becton Dickinson Vascular Access, Inc. FOZ Class II 1995-01-09
K941429 IV CATHETER AND OBTURATOR Becton Dickinson Vascular Access, Inc. FOS Class II 1995-01-04
K926139 CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH Bard Access Systems, Inc. LJT Class II 1995-01-03
K933602 PATIENT EXAMINATION GLOVE Kerala Rubber & Reclaims, Ltd. LYY Class I 1995-01-02
K945247 POWDERFREE LATEX EXAMINATION GLOVE Sri Johani Sdn. Bhd. LYY Class I 1995-01-02
K945045 PATIENT EXAINATION GLOVES Phoenix Medical Technology, Inc. LYY Class I 1995-01-02
K945284 TRUJECT Clive Craig Co. FMI Class II 1994-12-29
K945577 GUARDIAN II GLOVE Guardian Group, Inc. LZC Class I 1994-12-29
K945190 STERRAD CHEMICAL INDICATOR TAPE Advanced Sterilization Products JOJ Class II 1994-12-29
K944411 P/2000 Plexus Medical FNM Class II 1994-12-27
K944041 PERSONAL HEARING SYSTEM Resound Corp. LRS Class II 1994-12-27
K944240 SOFT SOCK Silipos, Inc. FQL Class I 1994-12-27
K944881 SKIN SCRUB TRAY Clinical Resources, Inc. FRG Class II 1994-12-27
K943097 CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM Global Medical Technologies, Inc. FNM Class II 1994-12-23
K942770 ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR Ultimate Development Corp. KMI Class I 1994-12-23
K905119 PLAZLYTE(TM) Abtox, Inc. FLF Class II 1994-12-22
K923442 ABTOX PLAZLYTE PROCESS MONITOR Abtox, Inc. FLF Class II 1994-12-22
K941327 CROSSTEX SELF-SEALING STERILIZATION POUCH Cross Country Paper Products Corp. KCT Class II 1994-12-22
K923739 ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR Abtox, Inc. FRC Class II 1994-12-22

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