meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
39
Latest Decision
1994-10-19

Clearances · page 94 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K935280 MEMOTHERM 10 BABY THERMOMETER International Regulatory Consultants FLL Class II 1994-10-19
K943734 MEDICAL SUPPORT STOCKINGS 2001/2002 Julius Zorn, Inc. DWL Class II 1994-10-19
K944510 VINYL EXAMINATION GLOVE, POWDER-FREE American Gemini, Inc. LYZ Class I 1994-10-18
K943575 B-D GUARDIAN NESTABLE SHARPS COLLECTORS Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1994-10-14
K940634 MICRO THERAPEUTICS INFUSION CATHETER Micro Therapeutics, Inc. FOZ Class II 1994-10-14
K935090 CUFF-CATH Ohmeda Medical FOZ Class II 1994-10-14
K942149 POWDERED DISPOSABLE LATEX EXAM GLOVES/ANNEXURES Ti-Mate Prophylactic Devices , Ltd. LYY Class I 1994-10-13
K940872 PATIENT SUPPORT SYSTEM Arylift, Inc. FNG Class II 1994-10-13
K944141 COMFIT (STERILE) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-10-13
K942625 1.2 MICRON AIR ELIMINATING FILTER The Medi-Dose Group FPB Class II 1994-10-07
K944033 BILL EVANS-KLENZ Calgon Vestal Div. FLG Class I 1994-10-07
K942686 NORELCO CLEAN AIR SYSTEM MODEL CAM665 Norelco Consumer Products Co. FRF Class II 1994-10-07
K942643 ENSURE POWDER-FREE LATEX PATIENT EXAMINATION GLOVES Basic Intl., Inc. LYY Class I 1994-10-07
K942877 EXAMINATION GLOVES Masif Healthcare Products Sdn. Bhd. LYY Class I 1994-10-07
K941417 VITAFLON PLUS/VASCULON Hogan & Hartson FOZ Class II 1994-10-06
K944177 BREAST SHELL O'Donnell, Byrne & Williams HFS Class I 1994-10-05
K944117 AVENT NIPPLE SHIELD Avent America, Inc. HFS Class I 1994-10-05
K942046 PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE Pharmacia Deltec, Inc. FPA Class II 1994-10-04
K943529 PATIENT TROLLEY 540 Merivaara Instrumentarium Corp. FPO Class II 1994-10-04
K943781 ACRYDERM ADVANCED WOUND DRESSING Acrymed, Inc. KMF Class I 1994-10-04
K943528 PATIENT TROLLEY 545 Merivaara Instrumentarium Corp. FPO Class II 1994-10-04
K941214 LIFESHIELD EXTENSION SET Abbott Mfg., Inc. FPK Class II 1994-10-03
K940536 BAND-AID(TM) BRAND ADHESIVE BANDAGE Johnson & Johnson Consumer Products, Inc. KGX Class I 1994-10-03
K932204 E-Z THERM 3 SECOND THERMOMETER North American Technical Services Corp. FLL Class II 1994-10-03
K943636 CURADERM ALGINATE HYDROCOLLOID Kendall Healthcare Products Co. Div.Of Tyco Health KMF Class I 1994-10-03
K941788 BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP Johnson & Johnson Consumer Products, Inc. KGX Class I 1994-10-03
K943095 IV TRANSFER SPIKE Migada, Ltd. LHI Class II 1994-09-30
K941814 ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER Sherwood Medical Co. FOS Class II 1994-09-30
K943023 CVD BULLETT PERIPHERAL INFUSION CATHETER Cardiovascular Dynamics, Inc. FOZ Class II 1994-09-30
K933545 SIEMENS FLUID DELIVERY SYSTEM, MMT-9500 Siemens Infusions Systems FRN Class II 1994-09-29
K943262 FUTURA JUNIOR 300/310 Merivaara Instrumentarium Corp. FPO Class II 1994-09-29
K943127 PHARMASSURE LARGE VOLUME TRANSFER FILTERS Gelman Sciences, Inc. FPB Class II 1994-09-29
K943181 DISPENSING PIN WITH ONE-WAY VALVE B. Braun of America, Inc. LHI Class II 1994-09-29
K943147 STATLOCK CV Venetec, Inc. KMK Class I 1994-09-29
K943807 ROYAL SHIELD PINK COLORED NON-STERILE LATEX EXAMINATION GLOVE Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1994-09-29
K943360 OHIO CARE PLUS INCUBATOR Ohmeda Medical FMZ Class II 1994-09-29
K940798 SHIPPERT PRESSURE BANDAGE Denver Splint Co. KGX Class I 1994-09-28
K943043 ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-BUBBLE GUM Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1994-09-26
K943044 ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-STRAWBERRY Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1994-09-26
K922440 STERIKING, SEE & PEEL Cox Sterile Products, Inc. KCT Class II 1994-09-26
K943434 PATIENT EXAMINATION GLOVES Pacewell Sdn Bhd LYY Class I 1994-09-26
K943587 ADVANCED IN-BED WEIGH SYSTEM Future Systems, Inc. FRW Class I 1994-09-22
K931509 GERITREX STERILE SALINE SOLUTION FOR IRRIGATION Geritrex Corp. JOL Class II 1994-09-22
K933552 PM-PAGER Hill Engineering KMI Class I 1994-09-22
K942920 MEDAIR EXCEL 2000 Medifloat, Inc. FNM Class II 1994-09-19
K932411 VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA Med Institute, Inc. LJT Class II 1994-09-19
K942903 SHARPS-TAINER SMALL OPENING Winfield Co., Inc. FMI Class II 1994-09-19
K932550 POWDER FREE EXAMINATION GLOVES Unigloves , Ltd. LYY Class I 1994-09-19
K942901 SHARPS-TAINER LARGE OPENING Winfield Co., Inc. FMI Class II 1994-09-19
K935384 EXAMINATION GLOVES, POWDER FREE Jf Trading Co., Ltd. LYY Class I 1994-09-19
K940996 OLYMPIC BILI-LITE Olympic Medical Corp. LBI Class II 1994-09-16
K933454 DYNAMIC GERMICIDAL AIR PURIFICATION SYSTEM L&H Airco FRA Class II 1994-09-16
K942904 STABILET Hill-Rom, Inc. FMT Class II 1994-09-16
K943735 PROSHIELD PLUS MULTIPLE GLOVES Sino (U.S.A.) Co. LYY Class I 1994-09-16
K943047 IV START KITS Sterile Concepts, Inc. KMK Class I 1994-09-14
K940961 MONOJECT LUER ADAPTER Sherwood Medical Co. FMI Class II 1994-09-14
K943620 MICRO-TOUCH LATEX MEDICAL GLOVES Johnson & Johnson Medical, Inc. LYY Class I 1994-09-09
K943485 MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER Sherwood Medical Co. FMI Class II 1994-09-09
K934520 VITAL-PORT VASCULAR ACCESS SYSTEM Med Institute, Inc. LJT Class II 1994-09-06
K941589 SYRINGE FILTER DEVICES Gelman Sciences, Inc. FMF Class II 1994-09-06
K940406 DISPOSABLE, AMBULATORY, INFUSION PUMPS Vlv Associates, Inc. MEB Class II 1994-09-02
K941820 DUOTIP-TEST Lincoln Diagnostics, Inc. SCL Class II 1994-09-02
K940697 BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK Bd Becton Dickinson Vacutainer Systems Preanalytic FPA Class II 1994-08-30
K943496 MONOJECT TRAY SIZE SHARPS CONTAINER Sherwood Medical Co. FMI Class II 1994-08-29
K941991 IN-ROOM AND SHARPSTAR Sage Products, Inc. MMK Class II 1994-08-29
K942624 LOK-ON NEEDLE DISPOSAL CONTAINER Medical Safety Products, Inc. FMI Class II 1994-08-25
K942564 ARGYLE NEO-SERT Sherwood Medical Co. FOS Class II 1994-08-25
K941673 MEDIAID UNIVERSAL THERMOMETER Polymedica Industries, Inc. FLK Class II 1994-08-25
K942933 PRESSURE INFUSION CUFF Circulatory Technology, Inc. KZD Class I 1994-08-25
K942937 SHARPSAFE CAT NO. 4105, 4115 AND 4120 Smiths Industries Medical Systems, Inc. FMI Class II 1994-08-25
K943864 STRYKER 8000 SURGERY STRETCHER Stryker Medical FPO Class II 1994-08-25
K940573 HEPA AIR CLEANER Duracraft Corp. FRF Class II 1994-08-25
K942054 SHARPS-TAINER Winfield Industries FMI Class II 1994-08-23
K943578 MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER Sherwood Medical Co. FMI Class II 1994-08-23
K942623 TRIMPORT Gerard Medical Enterprises, Inc. LJT Class II 1994-08-23
K941389 EMPI TAPE PATCHES Empi KGX Class I 1994-08-23
K942383 DERMIVIEW CLEAR TAPE Johnson & Johnson International KGX Class I 1994-08-22
K943090 SUTURE REMOVAL TRAYS Sterile Concepts, Inc. FRG Class II 1994-08-22
K942412 THEREX LOW-PROFILE PORT - TITANIUM MODEL Therex Corp. LJT Class II 1994-08-19
K943619 CAVI-CARE CONFORMING FOAM DRESSING Smith & Nephew United, Inc. KMF Class I 1994-08-19
K943605 BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS Baxter Healthcare Corp FMI Class II 1994-08-17
K942532 2 MICRON AIR ELIMINATING FILTER Medi-Dose, Inc. FPB Class II 1994-08-17
K935267 B-D DIGITAL THERMOMETER Bd Becton Dickinson Vacutainer Systems Preanalytic FLL Class II 1994-08-17
K943594 BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS Baxter Healthcare Corp FMI Class II 1994-08-17
K933288 POWDERFREE LATEX EXAMINATION GLOVES Liwe Trading LYY Class I 1994-08-17
K941453 CHECK VALVE SOLUTION SET Douglas Medical Products Corp. FPA Class II 1994-08-16
K940446 3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION) Minnesota Mining and Mfg. Co. FRN Class II 1994-08-15
K924010 REDINOV PERFUSION SET Bipress, Inc. FPA Class II 1994-08-15
K934095 IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS Y FPA Class II 1994-08-10
K941020 DRUG RECONSTITUTION FILTER DEVICE Gelman Sciences, Inc. FMF Class II 1994-08-10
K935407 STICKIT E.M. Innovations, Inc. FMI Class II 1994-08-05
K942510 SCIPOTEX POWDER FREE EXAM GLOVES (UNBEADED) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-08-05
K942972 POWDER FREE VINYL PATIENT EXAMINATION GLOVES Lcl Taiwan & Co., Ltd. LYZ Class I 1994-08-05
K942221 IRRIGATION TRAY WITH PISTON SYRINGE Trinity Laboratories, Inc. FMF Class II 1994-08-05
K942042 POWDER FREE VINYL PATIENT EXAMINATION GLOVES Cheer & Merit Co., Ltd. LYZ Class I 1994-08-05
K941766 DIB INFUSOR Novacon Corp. MEB Class II 1994-08-05
K932057 BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK Board of Directors, Albert Browne , Ltd. JOJ Class II 1994-08-05
K943258 HYDROCOLLOID WOUND DRESSING Convatec, A Division of E.R. Squibb & Sons KMF Class I 1994-08-04
K942270 SAF-GEL HYDRATING DERMAL WOUND DRESSING Calgon Vestal Div. KMF Class I 1994-08-04
K941869 SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG The Lighthouse For the Blind, Inc. KZF Class I 1994-08-03

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