meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
32
Latest Decision
1994-12-22

Clearances · page 93 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K944479 PM3300 INTERMITTENT VACUUM Precision Medical, Inc. KDP Class II 1994-12-22
K944950 KLENZYME Calgon Corp. FLG Class I 1994-12-20
K944864 PRIMED RIGID CONTAINER SYSTEM Primed, Inc. KCT Class II 1994-12-20
K944920 CG DISPOSABLE SYRINGE Fortunique Medical Products FMF Class II 1994-12-20
K941595 MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5 Microject, Inc. FRN Class II 1994-12-19
K944854 STERISURE STERILIZATION WRAP Fiberweb North America, Inc. FRG Class II 1994-12-19
K943839 STERMED NON-CHLORINATED POWDER FREE GLOVES Steriltx (Usa), Inc. LYY Class I 1994-12-19
K944139 DENTAL HYGIENE TRAY Sterile Concepts, Inc. LYY Class I 1994-12-15
K942902 SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER Winfield Co., Inc. MMK Class II 1994-12-15
K945275 PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1 Pro-Tec Containers, Inc. FMI Class II 1994-12-14
K945276 PRO-TEC DISPOSABLE SHARPS CONTAINERS 5G Pro-Tec Containers, Inc. FMI Class II 1994-12-14
K943794 MX4000 Bfi- Medical Waste Systems FMI Class II 1994-12-14
K945274 PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80 Pro-Tec Containers, Inc. FMI Class II 1994-12-14
K943740 ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) Premium Plastics, Inc. FMI Class II 1994-12-14
K945055 HARKEN ASSURE SELF-SEAL STERILIZATION POUCH Harken Products, Inc. KCT Class II 1994-12-14
K942434 BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER Bionaire Corp. FRF Class II 1994-12-14
K945273 PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2 Pro-Tec Containers, Inc. FMI Class II 1994-12-14
K944208 IV ADMINISTRATION SET FPA Medex, Inc. FPA Class II 1994-12-13
K932521 POWDERFREE LATEX EXAMINATION GLOVES Top Glove Sdn. Bhd. LYY Class I 1994-12-13
K941450 INVIRO SYRINGE Dr. F. Ross Sharp , Ltd. MEG Class II 1994-12-12
K943900 LATEX MEDICAL GLOVE Johnson & Johnson Medical, Inc. LYY Class I 1994-12-12
K943353 PLEXUS/1000 Plexus Medical FNM Class II 1994-12-12
K943679 UNIVEC NONRESUSABLE LOCKING SYRINGE Univec, Inc. FMI Class II 1994-12-12
K933467 PRN ADAPTER Bd Becton Dickinson Vacutainer Systems Preanalytic FOZ Class II 1994-12-12
K941818 PM9000 VAC TRAP Precision Medical, Inc. KDQ Class II 1994-12-12
K936015 DISPOSABLE DISC FILTER Medi-Dose, Inc. FMF Class II 1994-12-12
K943733 FLEXIFLO SIX ENTERAL NUTRITION PUMP Abbott Mfg., Inc. LZH Class II 1994-12-12
K931318 3400 INFUSION PUMP Graseby Medical , Ltd. FRN Class II 1994-12-09
K945507 H 5100, H 5200, H 5300 Rudolf Riester GmbH & Co. KG KZF Class I 1994-12-09
K944182 POWDER FREE MEDICAL GLOVE Bd Becton Dickinson Vacutainer Systems Preanalytic LYZ Class I 1994-12-09
K944184 SYNTHETIC MEDICAL GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic LYZ Class I 1994-12-09
K943552 POWDER-FREE GLOVES Healthcare Gloves Sdn Bhd LYY Class I 1994-12-08
K943858 POWDER FREE (SILICONIZED) EXAM GLOVES Crocker Industrial Resources Sdn. Bhd. LYY Class I 1994-12-08
K945490 LATEX EXAMINATION GLOVE Masif Healthcare Products Sdn. Bhd. LYY Class I 1994-12-08
K942856 POWDER-FREE LATEX EXAMINATION GLOVES Pacificlink Exp.Industries Private , Ltd. LYY Class I 1994-12-07
K944355 NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES Nissho Corp. FMF Class II 1994-12-07
K936268 COMFIT BLUE POWDERED EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-12-07
K944140 COMFIT Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-12-07
K944125 ABBOTT LTE INFUSION PUMP Abbott Laboratories FRN Class II 1994-12-06
K931052 METRICIDE 28 Metrex Research Corp. MED Class II 1994-12-06
K931592 METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE Metrex Research Corp. MED Class II 1994-12-06
K930284 METRICIDE Metrex Research Corp. MED Class II 1994-12-06
K943270 SURFACE TEMPERATURE PROBES Coast Medical, Inc. FLL Class II 1994-12-05
K944114 PHLEBOTOMY UNIT SHARPS A GATOR Devon Industries, Inc. FMI Class II 1994-12-02
K945197 THE SHARPS COLLECTION AND DISPOSAL SYSTEM Devon Industries, Inc. MMK Class II 1994-12-02
K941748 STERI-VAC GAS STERILIZER MODEL 8XL 3M Health Care, Ltd. FLF Class II 1994-12-02
K944953 OREX MEDICAL BEDDING Thantex Specialties, Inc. KME Class I 1994-12-02
K943892 POINT OF USE SHARPS A GATOR Devon Industries, Inc. FMI Class II 1994-12-02
K942179 PRO-TEC DISPOSABLE SHARPS CONTAINERS Pro-Tec Containers, Inc. FMI Class II 1994-12-02
K944581 CUTINOVA THIN WOUND DRESSING Beiersdorf, Inc. KMF Class I 1994-12-02
K942947 COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-11-30
K936181 MIDMARK M-11 ULTRACLAVE STEAM STERILIZER Midmark Corp. FLE Class II 1994-11-30
K943707 LATEX EXAMINATION GLOVES Arista Latindo Industrial Ltd. P.T LYY Class I 1994-11-30
K941244 SAFELINE SYSTEM TURN LOCK CANNULA Mcgaw, Inc. FPA Class II 1994-11-29
K944468 KERLIX ZINC SALINE DRESSING Kendall Healthcare Products Co. Div.Of Tyco Health KMF Class I 1994-11-29
K945161 NORELCO CLEAN AIR SYSTEM CAS950 Hogan & Hartson FRF Class II 1994-11-28
K944514 P2 NITRILE EXAM GLOVES Biosafety Systems, Inc. LYZ Class I 1994-11-28
K943139 B-D GUARDIAN ONE PIECE SHARPS COLLECTORS Med-Safe Systems, Inc. FMI Class II 1994-11-28
K943238 NORELCO CLEAN AIR SYSTEM Philips Electronic North America Corp. (Pena) FRF Class II 1994-11-28
K943138 VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER Med-Safe Systems, Inc. MMK Class II 1994-11-28
K944927 NORELCO CLEAN AIR SYSTEM CAS900 Norelco Consumer Products Co. FRF Class II 1994-11-28
K943722 CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS Baxter Healthcare Corp FMI Class II 1994-11-28
K942683 BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550 Bionaire Corp. FRF Class II 1994-11-28
K944491 DERMAGRAN HYDROPHILIC OINTMENT Derma Sciences, Inc. KMF Class I 1994-11-22
K944929 OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905) Merivaara Instrumentarium Corp. FNK Class I 1994-11-22
K943836 PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER Orion Life Systems, Inc. JOL Class II 1994-11-21
K943834 STERILE .9% SODIUM CHLORIDE SOLUTION Orion Life Systems, Inc. JOL Class II 1994-11-21
K943828 STERILE WATER FOR IRRIGATION Orion Life Systems, Inc. JOL Class II 1994-11-21
K943830 PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION Orion Life Systems, Inc. JOL Class II 1994-11-21
K943832 STERILE .9% SODIUM CHLORIDE FOR IRRATION Orion Life Systems, Inc. JOL Class II 1994-11-21
K943829 PRE-FILLED SYSRINGE W/STERILE WATER Orion Life Systems, Inc. JOL Class II 1994-11-21
K943831 PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER Orion Life Systems, Inc. JOL Class II 1994-11-21
K942512 PA300 The Rival Co. FRF Class II 1994-11-18
K940807 SEE-THRU SELF SEALING STERILIZATION POUCH Asep-Pro, Inc. KCT Class II 1994-11-18
K944778 LATEX EXAMINATION GLOVES Pt. Haloni Jane OPE 1994-11-17
K945000 MULTIDEX HYDROPHILIC WOUND DRESSING Lange Medical Products, Inc. KMF Class I 1994-11-17
K932088 AUTOPAK STERILIZATION POUCH Ongard Meddevice Packaging, Inc. KCT Class II 1994-11-17
K932086 AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH Ongard Meddevice Packaging, Inc. KCT Class II 1994-11-17
K940319 R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE R-Group Intl. FPA Class II 1994-11-10
K943134 B-D GUARDIAN NESTABLE SHARPS COLLECTORS Med-Safe Systems, Inc. FMI Class II 1994-11-07
K943137 B-D/BFI MAIL DISPOSAL SERVICE Med-Safe Systems, Inc. FMI Class II 1994-11-07
K943136 B-D GUARDIAN POINT-OF-USE VERTICAL ENTRY SHARPS COLLECTORS Med-Safe Systems, Inc. FMI Class II 1994-11-07
K943141 B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS Med-Safe Systems, Inc. FMI Class II 1994-11-07
K944230 DIAL MEDICAL SUPPLY SHARPS CONTAINER Regulatory & Marketing Services, Inc. FMI Class II 1994-11-07
K940556 SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP Sandoz Nutrition LZH Class II 1994-11-07
K944588 STERILE PLASTIC DRESSING Smith & Nephew, Inc. KGX Class I 1994-11-07
K943135 MED-SAFE INSULIN SHARPS CONTAINER Med-Safe Systems, Inc. FMI Class II 1994-11-07
K943140 B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS Med-Safe Systems, Inc. FMI Class II 1994-11-07
K932138 SALINE FOR IRRIGATION Rantran, Inc. JOL Class II 1994-11-04
K943664 INTERMATE XLV ELASTOMERIC INFUSION SYSTEM Baxter Healthcare Corp MEB Class II 1994-11-03
K943481 INFORMER PLUS Micro-Tech Medical, Inc. KMI Class I 1994-11-02
K942827 SENTRY INSERTION TRAY Sentry Medical Products, Inc. FOS Class II 1994-11-02
K943833 STERILE WATER FOR IRRATION Orion Life Systems, Inc. JOL Class II 1994-11-01
K943683 B-D SAFE-CLIP Becton Dickinson Consumer Products FMI Class II 1994-10-31
K944142 P2 EXAM GLOVES Biosafety Systems, Inc. LYY Class I 1994-10-28
K944095 P2 NITRILE EXAM GLOVES Biosafety Systems, Inc. LYY Class I 1994-10-28
K943941 SAFESTART VASCULAR ACCESS START KIT Becton Dickinson Vascular Access, Inc. LRS Class II 1994-10-20
K942162 SIGMA 8000 AND SIGMA 8002 Sigma Intl. FRN Class II 1994-10-20
K941787 LATEX EXAM GLOVES P.T. Irama Dinamika Latex LYY Class I 1994-10-19
K944494 ALSA-KLENZ Calgon Vestal Div. FLG Class I 1994-10-19

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