meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
1995-07-14

Clearances · page 90 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K942988 FILTERED EXTENSION SETS B. Braun of America, Inc. FPA Class II 1995-07-14
K945592 VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE Vlv Associates, Inc. FMF Class II 1995-07-14
K952334 DRESSING CHANGE TRAY Busse Hospital Disposables, Inc. MCY Class II 1995-07-14
K952663 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP Distronic Sterile Products, Inc. FPK Class II 1995-07-14
K934435 CAP-STIK Mcshane Medical, Inc. FMI Class II 1995-07-14
K952420 STERIGAUZE WET DRESSING Acacia Laboratories, Inc. KMF Class I 1995-07-12
K943057 CAP SAFE SYSTEM Medical Safety Solutions FMI Class II 1995-07-12
K942271 LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE Level 1 Technologies, Inc. FPA Class II 1995-07-12
K951162 PHENO-CEN GERMICIDAL DETERGENT Central Solutions, Inc. LRJ Class I 1995-07-11
K946289 DEVONS POINT LOK NEEDLE PROTECTION DEVICE Devon Industries, Inc. FMI Class II 1995-07-10
K942930 CAPCARD Capcard, Inc. FMI Class II 1995-07-10
K943765 SHARPS AWAY Biomedical Waste Systems, Inc. FMI Class II 1995-07-10
K945942 AUTO SYRINGE(R) AS50 INFUSION PUMP Baxter Healthcare Corp FRN Class II 1995-07-10
K942989 OCR II & OCM II Chambermaid Products Co. FLE Class II 1995-07-07
K952408 ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION Pymah Corp. JOJ Class II 1995-07-06
K951524 THORACENTESIS CATHETER Baxter Healthcare Corp JOL Class II 1995-07-06
K952537 THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D. Therex Corp. LJT Class II 1995-07-06
K946189 INTROPORT(TM) CATHETER MODEL #1000(ICT) Lifequest Medical, Inc. LJT Class II 1995-07-06
K952367 CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE Cypress Medical Products, Ltd. LYY Class I 1995-07-05
K951736 LOCK-UP Medline FMI Class II 1995-07-05
K932922 PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR Cottrell, Ltd. MED Class II 1995-07-03
K950899 LABORATORY SHARPS BARREL Biosystems FMI Class II 1995-06-29
K951704 NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION Products For Medicine FRG Class II 1995-06-28
K942810 PALCO LABS COLD POUCH Palco Laboratories, Inc. LDQ 1995-06-28
K951703 TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS Products For Medicine LRT Class II 1995-06-28
K952702 DERMA SEAL Ttl Medical FPX Class I 1995-06-28
K943591 VECTOR(TM) AMBULATORY DRUG DELIVERY SYSTEM Infusion Technology Intl. FPA Class II 1995-06-28
K951940 PATIENT EXAMINATION GLOVE Lowenkamp Intl., Inc. LYY Class I 1995-06-28
K951469 BAZOOKA SYSTEM Innovative Medical Systems, Inc. FNM Class II 1995-06-28
K952556 SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE Aladan Corp. LYY Class I 1995-06-26
K941439 RENALIN COLD STERILANT Minntech Corp. LRJ Class I 1995-06-26
K941678 BIONECTOR Vygon Corp. FOZ Class II 1995-06-26
K951384 V-CATH PERCUTANEOUS INTRODUCER KIT Hdc Corp. KZH Class II 1995-06-23
K946021 VINYL POWDER-FREE EXAMINATION GLOVES Wilson Glove Products Co., Ltd. LYZ Class I 1995-06-23
K950357 SURVIVAL KIT Opportunity Resources, Inc. LYY Class I 1995-06-22
K951909 RYNEL MEDICAL FOAM Rynel, Ltd. Inc. KMF Class I 1995-06-21
K951871 PISTON SYRINGE Baxa Corp. FMF Class II 1995-06-21
K950419 THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS Imed Corp. FRN Class II 1995-06-21
K951983 IMNI-II Cottrell, Ltd. LRJ Class I 1995-06-20
K944750 CORFLO 300 PUMP Corpak, Inc. FRN Class II 1995-06-19
K946041 CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.) Cardico, Inc. FMI Class II 1995-06-16
K951730 SPYROFOAM WOUND DRESSING Polymedica Industries, Inc. KMF Class I 1995-06-16
K943626 ISOLYSER SHARPS MANAGEMENT SYSTEM SMS Thantex Specialties, Inc. FMI Class II 1995-06-16
K930521 AIR CLEANERS WITH HEPA FILTRATION The Rival Co. FRF Class II 1995-06-16
K951839 ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES Aladan Corp. LYY Class I 1995-06-15
K951670 DISPOSABLE LATEX PATIENT EXAMINATION GLOVES Emi Groups (U.S.A.), Inc. LYY Class I 1995-06-15
K951988 PRESSURIZER Promedic, Inc. KZD Class I 1995-06-14
K952335 WOUND CARE MANAGEMENT KITS Continental Medical Laboratories, Inc. LYY Class I 1995-06-14
K945298 SMARTFLOW I ADMINISTRATION SET River Medical, Inc. FPA Class II 1995-06-14
K951119 NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM American Hydro-Surgical Instruments, Inc. GCX Class II 1995-06-13
K951076 VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM Med Institute, Inc. LJT Class II 1995-06-13
K950191 THE LOTECON PERSONAL CARE SYSTEM Lotecon, Inc. FNM Class II 1995-06-12
K951022 CIRCULON SYSTEM STEP 1 Convatec, A Division of E.R. Squibb & Sons MCY Class II 1995-06-12
K951021 CIRCULON SYSTEM STEP 2 Convatec, A Division of E.R. Squibb & Sons MCY Class II 1995-06-12
K933569 PENT NOVA AUTOBLOCK SYRINGE Medi-Hut Co., Inc. MEG Class II 1995-06-09
K950685 BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING Bioderm, Inc. KMF Class I 1995-06-09
K946257 LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC) Siam Sempermed Corp., Ltd. LYY Class I 1995-06-08
K945956 STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS Strato Medical Corp. LJS Class II 1995-06-06
K951112 PRESSUREGUARD IV Span-America Medical Systems, Inc. FNM Class II 1995-06-06
K951619 UNIVEC NONREUSABLE LOCKING SYRINGE Univec, Inc. FMF Class II 1995-06-06
K951024 NATURE'S CRADLE Infant Advantage, Inc. FMS Class II 1995-06-05
K950340 IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS Bemis Mfg. Co. MMK Class II 1995-06-02
K951098 HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER Hdc Corp. LJS Class II 1995-06-02
K950450 POWDER FREE LATEX EXAMINATION GLOVES Rampart Glove Co. LYY Class I 1995-06-02
K950622 MEGA MEDITEX LIMITED Mega Meditex , Ltd. LYY Class I 1995-06-02
K950987 STRATO/INFUSAID TUNNELER Strato/Infusaid, Inc. LJS Class II 1995-06-02
K952053 E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS Becton Dickinson Vascular Access, Inc. FPA Class II 1995-05-31
K945752 CELSITE(TM) BRACHIAL VENOUS PORT B. Braun of America, Inc. LJT Class II 1995-05-31
K950861 RECONSTITUTION ACCESSOREIS Organon, Inc. FPK Class II 1995-05-26
K951513 JAI Intl. Trade Management Co. LYY Class I 1995-05-25
K951875 STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM Strato/Infusaid, Inc. LJT Class II 1995-05-24
K945728 CATCO THORACIC CATHETER Catco Medical, Inc. JOL Class II 1995-05-23
K951515 MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER Sherwood Medical Co. FMI Class II 1995-05-23
K944190 LIFECARE 175 INFUSER, MODIFICATION Abbott Laboratories FRN Class II 1995-05-23
K933524 EXTENTION SET Mediziv Medical Products 1987 , Ltd. FPK Class II 1995-05-23
K951476 E-PACK PROCEDURE KITS ETHICON, Inc. MCY Class II 1995-05-23
K944094 TRIADYNE Kinetic Concepts, Inc. FNM Class II 1995-05-23
K950284 SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR Sims Deltec, Inc. FOZ Class II 1995-05-23
K951874 STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM Strato/Infusaid, Inc. LJT Class II 1995-05-19
K945797 STERILE EMPTY PCA SYRINGE Intl. Medication Systems, Ltd. FMF Class II 1995-05-19
K951295 STERRAD STERILIZATION POUCH Advanced Sterilization Products KCT Class II 1995-05-19
K933523 I.V. FILTER SET Mediziv Medical Products 1987 , Ltd. FPB Class II 1995-05-19
K945053 LF CT HIG PRESSURE CATHETERS Mallinckrodt Group, Inc. FOZ Class II 1995-05-19
K951873 STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM Strato/Infusaid, Inc. LJT Class II 1995-05-19
K951234 MEDICAL SUPPORT STOCKINGS Jobst A Beiersdorf Co. DWL Class II 1995-05-18
K951872 STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM Strato/Infusaid, Inc. LJT Class II 1995-05-18
K951590 ASSURE, SELF-SEALING STERILIZATION POUCH Sultan Chemists, Inc. KCT Class II 1995-05-17
K951668 SCIPOTEX/POWDER FREE EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-05-17
K951667 COMFIT/GREEN POWDERED EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-05-17
K946084 VANGUARD Vanguard Container Corp. FMI Class II 1995-05-17
K943601 COMFIT (PINK) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-05-17
K951167 EMS I.V. START KIT Emergency Medical Supply, Inc. LRS Class II 1995-05-16
K936225 TS1 TURTLE(TM) SYRINGE Kershenstine Diamond, Inc. MEG Class II 1995-05-16
K951914 HYDRACARE ABSORBENT WOUND DRESSING Acacia Laboratories, Inc. KMF Class I 1995-05-15
K945193 ALL-IN-ONE TWO CHAMBER CONTAINER Baxter Healthcare Corp KPE Class II 1995-05-12
K950466 B-D ULTRA-FINE II PEN NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1995-05-11
K950823 ANDAL Pt. Sarana Indoprotex LYY Class I 1995-05-10
K951063 ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION Pymah Corp. JOJ Class II 1995-05-10
K951161 MC ACCLAIM Q6000 BED Janco Consulting Services FNL Class II 1995-05-09
K935755 THE ULTRA Medical Device Systems, Inc. KCT Class II 1995-05-05

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