meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
1996-07-26

Clearances · page 85 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K962189 COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1996-07-26
K961287 ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM Rocket Medical Plc KDQ Class II 1996-07-26
K962787 TAKI DISPOSABLE ACUPUNCTURE NEEDLE Acupuncture Supplies Import Co. MQX Class II 1996-07-26
K954293 PATIENT EXAMINATION GLOVE (POWDERED) Medline Products Co. , Ltd. LYY Class I 1996-07-26
K962188 COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1996-07-26
K962419 CW-DISPOSABLE ACUPUNCTURE NEEDLE Acupuncture Supplies Import Co. MQX Class II 1996-07-25
K960833 VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM Uv Technologies, Inc. FRA Class II 1996-07-25
K953811 MEDCOMP P-CATH Medcomp FOZ Class II 1996-07-25
K961675 BG PATIENT EXAMINATION GLOVES, NON-STERILE Biografik (Malaysia) Sdn Bhd LYY Class I 1996-07-25
K955606 PISTON SYRINGE Medical Surgical Intl. FMF Class II 1996-07-25
K961470 PORT-A-POLE Prins Medical Ind., Inc. FOX Class I 1996-07-22
K962168 MUCUS SPECIMEN TRAP Sage Products, Inc. KDQ Class II 1996-07-22
K961652 LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017 Arrow Intl., Inc. LJT Class II 1996-07-19
K961615 LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037 Arrow Intl., Inc. LJT Class II 1996-07-19
K961880 MEDCARE SUCTION CONNECTING TUBING Medcare Medical Group, Inc. GCX Class II 1996-07-19
K962070 YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE Yellow Springs Instrument Co., Inc. FLL Class II 1996-07-19
K961336 MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652 Medtronic PS Medical LJS Class II 1996-07-18
K955231 MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP Medex, Inc. FRN Class II 1996-07-18
K962123 AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM Lumex, Inc. FNM Class II 1996-07-18
K961583 A PORT DETACHED CATHETER SYSTEM CATALOG #1002 Arrow Intl., Inc. LJT Class II 1996-07-18
K961856 AUTO SUTURE CHEMOSITE TUNNELER United States Surgical, A Division of Tyco Healthc LJS Class II 1996-07-18
K961502 LUBRICATING JELLY, LOW VISCOSITY Span-America Medical Systems, Inc. KMJ Class I 1996-07-18
K960725 MARPP PRESSURE MONITORING SYSTEM Paradigm Medical, Inc. KYZ Class I 1996-07-15
K962421 SORBCEL ALGINATE/CMC WOUND DRESSING Innovative Technologies , Ltd. KMF Class I 1996-07-11
K955821 I.V. ADMINISTRATION SETS Medical Associates Network, Inc. FPA Class II 1996-07-10
K960769 ACUPUNCTURE NEEDLE PACK Acu-Med, Inc. MQX Class II 1996-07-10
K961703 COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL) Baxter Healthcare Corp FRN Class II 1996-07-08
K955772 CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES Ttk Biomed, Ltd. FMI Class II 1996-07-08
K960882 CONTROL SYRINGE Louisville Laboratories, Inc. FMF Class II 1996-07-08
K960391 STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771 Strato/Infusaid, Inc. FPA Class II 1996-07-03
K962290 DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER Debusk Technology Corp. FOK Class I 1996-07-03
K961339 CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES Helio Medical Supplies, Inc. MQX Class II 1996-07-03
K961088 NON-CORING NEEDLE Arrow Intl., Inc. FMI Class II 1996-07-02
K953805 0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE Abbott Laboratories FOZ Class II 1996-06-28
K961878 SHARPS-TAINER Winfield Industries FMI Class II 1996-06-27
K961230 EASTERCLAVE Easter Services, Inc. FLE Class II 1996-06-27
K953590 COMFIT Wembley Rubber Products (M) Sdn Bhd LYY Class I 1996-06-27
K960746 SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES Sunmax Enterprise Shanghai Co. , Ltd. LYZ Class I 1996-06-27
K961251 PUNCTUR-GUARD WINGED SET Bio-Plexus, Inc. FMI Class II 1996-06-27
K955918 SINOCHEM NINGBO LATEX EXAMINATION GLOVE, POWDER FREE Sinochem Ningbo Imp & Exp Corp. LYY Class I 1996-06-27
K961495 HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE Baxter Healthcare Corp FPA Class II 1996-06-26
K961222 EVRON GEL Pharmaceutical Innovations, Inc. KMJ Class I 1996-06-26
K962035 GE STERILE ARTHROGRAM TRAY GE Medical Systems FMI Class II 1996-06-25
K962040 RNS ARTHROGRAM TRAY Contour Fabricators of Florida, Inc. FMI Class II 1996-06-25
K961225 CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET Baxter Healthcare Corp FPA Class II 1996-06-21
K954792 LUMISCOPE MODEL 2018 THERMOMETER Lumiscope Co., Inc. FLL Class II 1996-06-21
K960386 HANDSAFE Handsafe Products Sdn. Bhd. LYY Class I 1996-06-21
K961323 LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING Acme United Corp. KMF Class I 1996-06-19
K961155 SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 Douglas Medical Products Corp. LJS Class II 1996-06-18
K954302 VYGON PREMI-CATH - LONG TERM CATHETER Vygon Corp. LJS Class II 1996-06-17
K961159 POWERED LOW AIR LOSS MATTRESS SYSTEM Span-America Medical Systems, Inc. FNM Class II 1996-06-14
K961662 ADVANCED CARE HYDROPHILIC WOUND DRESSINGS Mariner Biomedical, Inc. KMF Class I 1996-06-13
K955424 OSTAR Ultravena Industries, Ltd. LYY Class I 1996-06-10
K955947 OSTAR EXAMINATION GLOVES Contract Latex Dippers Sdn Bhd LYY Class I 1996-06-10
K961227 JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY J.J. Skinner, Inc. FRG Class II 1996-06-10
K961879 ELECTRONIC THERMOMETER Wiltec Industries , Ltd. FLL Class II 1996-06-10
K961309 POS-T-VAC ID-300 Pos-T-Vac, Inc. KZH Class II 1996-06-10
K955776 ACU-LAB Glederer & Co., Inc. LDQ 1996-06-05
K954063 GLOVE SEAL & SET-RITE Contract Latex Dippers Sdn Bhd LYY Class I 1996-06-05
K960957 EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK Sims Deltec, Inc. FRN Class II 1996-06-04
K955258 3030 INFUSION PUMP Sabratek Corp. FRN Class II 1996-06-03
K961437 WHEELED STRETCHER Hill-Rom, Inc. FPO Class II 1996-06-03
K961452 LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING Acme United Corp. KMF Class I 1996-05-31
K955453 ACTICOAT SILVER COATED DRESSING Westaim Technologies, Inc. KMF Class I 1996-05-31
K961328 BEC SHROUDED PLASTIC CANNULA Biological & Environmental Control Laboratories FMI Class II 1996-05-30
K960466 IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) Abbott Laboratories LHI Class II 1996-05-29
K954283 ENERGIZED CONTAINER SYSTEM (MODIFICATION) Abbott Laboratories FPA Class II 1996-05-29
K932889 PERRY SPECIALTIES DESIGNS NEEDLE GUARD Perry Specialties Design, Inc. FMI Class II 1996-05-28
K955241 HIGH RISK GLOVES Pan-Century Rubber Products Sdn. Bhd. LYY Class I 1996-05-28
K954826 DISETRONIC MULTIFUSE PUMP SYSTEM Disetronic Medical Systems FRN Class II 1996-05-24
K960047 BRANNON PEDI PORTSYRINGE James K. Brannon FMF Class II 1996-05-24
K954258 TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) Gerard Medical Enterprises, Inc. LJT Class II 1996-05-24
K960467 POWDER FREE LATEX EXAMINATION GLOVE Biopro, Inc. LYY Class I 1996-05-24
K960049 BRANNON PORTSYRINGE James K. Brannon FMF Class II 1996-05-24
K960931 CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING Carolina Narrow Fabric Co. DWL Class II 1996-05-23
K955180 CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP Sims Deltec, Inc. FRN Class II 1996-05-23
K960777 MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR Mdt Corp., Inc. FRC Class II 1996-05-23
K960747 NATURE'S CRADLE MODEL C1500 Infant Advantage, Inc. FMS Class II 1996-05-22
K953940 TERUMO RETRACTABLE NEEDLE (RN) SYRINGE Terumo Medical Corp. FMF Class II 1996-05-21
K960641 RECAP-1 Medscience, Inc. FMI Class II 1996-05-17
K961327 BEC NEEDLELESS INJECTION SITE Biological & Environmental Control Laboratories FPA Class II 1996-05-15
K960277 PROTECTIVE LATEX POWDERED GLOVES Highactive Sdn. Bhd. LYY Class I 1996-05-15
K955585 V2 INJECTION SITE B.Braun Medical, Inc. FPA Class II 1996-05-15
K955659 DRUGBOX C.F. Electronics, Inc. LGZ Class II 1996-05-14
K954112 VYGON LIFEVAC MID-LINE TRAY Vygon Corp. FOZ Class II 1996-05-09
K960963 CORD WRAP WITH NEEDLE RESHEATHER Osborn Medical Corp. FMI Class II 1996-05-06
K955410 SNAPDOSE DEVICE Abbott Laboratories FPA Class II 1996-05-06
K961474 POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133 Medtronic Minimed FPA Class II 1996-05-06
K960616 VITAFLOW SUCTION/ASPIRATION TUBING SET Vital Concepts, Inc. BYY Class II 1996-05-06
K955282 THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS Thermogenesis Corp. FMF Class II 1996-05-06
K954221 POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES Hartalega Sdn Bhd LYY Class I 1996-05-03
K960080 ACCUTEMP PROBE Kentec Medical, Inc. FMT Class II 1996-05-01
K960581 SECURE EVA DUAL CHAMBER MIXING BAG Secure Medical Products, Inc. KPE Class II 1996-04-30
K960001 MINIMED INFUSION PUMP, MODEL MMT-507 Medtronic Minimed LZG Class II 1996-04-30
K953300 V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER Hdc Corp. LJS Class II 1996-04-30
K955889 POWDERFREE LATEX EXAMINATION GLOVES Pantai Utama Sdn. Bhd. LYY Class I 1996-04-26
K955341 NIL LATEX POWDERFREE EXAMINATION GLOVES Shangrila Latex Industries Pvt. , Ltd. LYY Class I 1996-04-26
K960572 THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER Arrow Intl., Inc. LJT Class II 1996-04-26
K955888 PREPOWDERED LATEX EXAMINATION GLOVES Pantai Utama Sdn. Bhd. LYY Class I 1996-04-26
K960585 WOUND CARE COMPRESSION SYSTEM (WCCS) Suncoast Medical Products, Inc. MCY Class II 1996-04-26

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