meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
1995-11-14

Clearances · page 88 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K954857 COMFEEL:ALGINATE FILLER Coloplast Corp. KMF Class I 1995-11-14
K952565 LYOFOAM EXTRA Acme United Corp. KMF Class I 1995-11-14
K953939 QUINTEST Bayer Corp. SCL Class II 1995-11-13
K954337 GENOTROPIN MIXER Pharmacia, Inc. FMF Class II 1995-11-13
K953829 SAFE-T-SEAL Gs Medical Packaging, Inc. KCT Class II 1995-11-09
K954230 SORBSAN PLUS TOPICAL WOUND DRESSING Dow Hickam Pharmaceuticals, Inc. KMF Class I 1995-11-08
K954295 MARLENE STOCKINGS & TIGHTS Professional Products, Inc. DWL Class II 1995-11-08
K953196 CARDIO-SYSTEMS PRO-OP Ch Administration, Inc. FNM Class II 1995-11-08
K953735 AUTOJECT MINI Owen Mumford USA, Inc. KZH Class II 1995-11-08
K953864 SILCLEAR TUBING (MODIFICATION) Degania Silicone , Ltd. FPK Class II 1995-11-06
K953709 DERRICK SAFETOUCH M.P.S. Pharm'L Int'L LYY Class I 1995-11-06
K935916 LIP GRIP CAP HOLDER Daryl C. Fallas FMI Class II 1995-11-03
K950508 SYSMEX SF-3000 Sysmex Corp. FPK Class II 1995-11-03
K946170 COMFORT-Q SUBCUTANEOUS INJECTION SETS B. Braun of America, Inc. FOZ Class II 1995-11-03
K954081 PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE) Tan Chong Rubber Gloves Sdn Bhd LYY Class I 1995-10-30
K952052 SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD) Wembley Rubber Products (M) Sdn Bhd LZA Class I 1995-10-30
K944587 DERMIVIEW HYPOALLERGENIC CLEAR TAPE Johnson & Johnson Medical, Inc. KGX Class I 1995-10-30
K953536 SLANT/FIN HEPA CLEAR Amcor, Ltd. FRF Class II 1995-10-30
K953791 VLV SA EF INFUSION PORT Vlv Associates, Inc. FPA Class II 1995-10-30
K951921 SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES) Wembley Rubber Products (M) Sdn Bhd LZA Class I 1995-10-30
K953343 NEEDLELESS INJECTION SITE Medical Associates Network, Inc. FPA Class II 1995-10-26
K951919 B-D PEN ULTRA Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1995-10-24
K953503 PRESSUREGUARD IV Span-America Medical Systems, Inc. FNM Class II 1995-10-24
K953584 LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG Abbott Laboratories FPA Class II 1995-10-24
K953749 MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS Curwood, Inc. KCT Class II 1995-10-19
K953986 POWDERFREE LATEX GLOVE Steriltx LYY Class I 1995-10-19
K950566 DECOMAT 4656 Getinge Disinfection, Inc. LDS Class II 1995-10-19
K954189 EASI-JECTOR CONTROL SYSTEM North, Inc. FMF Class II 1995-10-19
K951025 PISTON SYRINGE Pharmacia, Inc. FMF Class II 1995-10-19
K953382 ACCUPUMP 901 (MODEL NUMBERS 50 & 100) Pharmaceutical Infusion Technologies, Inc. FRN Class II 1995-10-17
K951665 PP-SPF1 / PP-SPF2 Patriot Products, Inc. FPA Class II 1995-10-17
K953660 PLUM XL INFUSION PUMP (MODIFICATION) Abbott Laboratories FRN Class II 1995-10-17
K954041 G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES) Glaxo, Inc. FMI Class II 1995-10-16
K952765 DELWA-STAR PACIFIER THERMOMETER Zewa, Inc. FLL Class II 1995-10-13
K950305 QTMICRO(TM) SYSTEM Q.I. Medical, Inc. LHI Class II 1995-10-13
K952588 ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. LYY Class I 1995-10-12
K953740 FOR MED HIGH RISK For Med, Inc. LYY Class I 1995-10-12
K953776 STERIKING STERILIZATION POUCHES & ROLLS Wihuri OY KCT Class II 1995-10-12
K952473 POWDER-FREE LATEX EXAMINATION GLOVE M.M.R. Gloves Private , Ltd. LYY Class I 1995-10-12
K945506 ACRYLIC DIPPED LATEX EXAMINATION GLOVES Ganz Industries Sdn. Bhd. LYY Class I 1995-10-12
K951981 RXAIR 3000 Clean Air Research & Development FRA Class II 1995-10-12
K943952 DISETRONIC D-MODEM Disetronic Medical Systems FRN Class II 1995-10-07
K951254 SAFETYGLIDE NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1995-10-07
K953290 OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP Olympus America, Inc. KZD Class I 1995-10-07
K952929 LD GENERAL PURPOSE DISINFECTANT Alcide Corp. LRJ Class I 1995-10-07
K953270 MODEL 1100 MEDMATE INFUSION PUMP Patient Solutions, Inc. FRN Class II 1995-10-07
K953573 ICU STOPCOK WITH EXTENSION TUBING Icu Medical, Inc. FMG Class II 1995-10-07
K953403 DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS Deroyal Industries, Inc. KMF Class I 1995-10-06
K953256 STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS Strato/Infusaid, Inc. LJS Class II 1995-10-04
K952201 PORT-A-CATH ACCESS KIT Medi-Flex Hospital Products, Inc. FMF Class II 1995-10-04
K953436 STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM Strato/Infusaid, Inc. LJS Class II 1995-10-04
K952553 ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE Alpha Medica FMF Class II 1995-10-03
K952834 SHROUDED PLASTIC CANNULA Medical Associates Network, Inc. FMI Class II 1995-10-03
K953571 VASPORT VASCULAR ACCESS PORT Gish Biomedical, Inc. LJT Class II 1995-10-02
K953474 IV START KIT Medikmark, Inc. FPA Class II 1995-10-02
K953678 STERIMED STERIZATION WRAPPER (NON-STERILE) Customed, Inc. FRG Class II 1995-10-02
K951738 ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER Sherwood Medical Co. FOS Class II 1995-09-29
K953241 EXSPOR Alcide Corp. LRJ Class I 1995-09-29
K952738 SKIN SAVER SYSTEMS Skin Saver Systems, Inc. FQM Class I 1995-09-29
K953497 COMFEEL:ALGINATE DRESSING Coloplast A/S KMF Class I 1995-09-29
K944542 REUSABLE ALL - GLASS SYRINGES Top Syringe Mfg. Co. FMF Class II 1995-09-29
K951557 EASTERCLAVE Easter Services, Inc. FLE Class II 1995-09-29
K954059 TITAN 20 CC DRIVER I-Flow Corp. MEB Class II 1995-09-29
K951737 ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY Sherwood Medical Co. FOS Class II 1995-09-28
K953675 ALTADYNE Lumex, Inc. FNM Class II 1995-09-28
K953028 TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET I-Flow Corp. MEB Class II 1995-09-28
K953225 IVAC BALL VALCE ADMIN. SETS Y FPA Class II 1995-09-27
K953379 HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE Ansell, Inc. LYY Class I 1995-09-27
K933898 HUBER NEEDLE SETS Mediziv Medical Products 1987 , Ltd. FPA Class II 1995-09-27
K954292 Q5. 5-5.5NPB-2.5HW Central Solutions, Inc. LRJ Class I 1995-09-27
K950143 ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE Astral, Ltd. FMT Class II 1995-09-25
K946005 ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE Astral, Ltd. FMT Class II 1995-09-25
K952159 BASIS DIGITAL THERMOMETER Polymedica Industries, Inc. FLL Class II 1995-09-22
K953138 MEDI-PLUS, HEALTH PLUS, SANITEX, RELIANCE Pwa Industries Sdn. Bhd. LYY Class I 1995-09-22
K953645 OLYMPIC PASTEURMATIC SYSTEM Olympic Medical Corp. LDS Class II 1995-09-22
K951980 COLLAPSIBLE HYPODERMIC SYRINGE Roman Vladimirsky FMF Class II 1995-09-22
K952835 WELCH ALLYN VIDEO EPISCOPE Welch Allyn, Inc. KZF Class I 1995-09-22
K952160 INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) Medex, Inc. FPA Class II 1995-09-21
K952058 STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE Trinity Laboratories, Inc. FOZ Class II 1995-09-21
K951666 STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS Stryker Instruments FQH Class II 1995-09-19
K933825 ADI SYSTEM Abbott Laboratories FRN Class II 1995-09-19
K953073 LOW PROFILE TITANIUM MODEL CATALOG #1003 Arrow Intl., Inc. LJT Class II 1995-09-19
K952918 PTFE SYRINGE FILTER B.Braun Medical, Inc. FMF Class II 1995-09-15
K952605 SUCTION/IRRIGATOR TUBING KIT Surgical Laser Technologies, Inc. GAZ Class II 1995-09-15
K952242 TRANSFEER SPIKE II The Medi-Dose Group FPA Class II 1995-09-15
K953019 HYDROPHILIC FOAM DRESSING Busse Hospital Disposables, Inc. KMF Class I 1995-09-15
K952976 PLASTIC BLUNT CANNULA Marquette Medical, Inc. FPA Class II 1995-09-15
K952794 HARVARD 2 SYRINGE PUMP Harvard Apparatus, Inc. FRN Class II 1995-09-15
K952610 PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500) Plexus Medical FNM Class II 1995-09-13
K953110 LOW PROFILE TITANIUM MODEL CATALOG #1003 Therex Corp. LJT Class II 1995-09-13
K953017 LOW PROFILE TITANIUM MODEL CATALOG #1003 Therex Corp. LJT Class II 1995-09-08
K953496 ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXAMINATION GLOVES Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1995-09-08
K952810 DOSI-FLOW, MODELS 20 & 30 Leventon, S.A. FPA Class II 1995-09-08
K953131 EXUSORB STERILE ABSORBENT O.R. Resources, Inc. KMF Class I 1995-09-08
K953070 WOUNDFOAM 4 X 4 Trinity Laboratories, Inc. KMF Class I 1995-09-08
K944133 MTB 1043 TREATMENT BOOTH Mark Solutions, Inc. LGM Class II 1995-09-07
K953231 PPMI-(XXX) AND PPMO-(XXX) Patriot Products, Inc. FPA Class II 1995-09-07
K952833 AMPRI Ampri Rubberware Industries Sdn Bhd LYY Class I 1995-09-05
K932946 WALLACE IV CANNULA Smiths Industries Medical Systems, Inc. FOZ Class II 1995-09-01
K932947 WALLACE Y-CAN Smiths Industries Medical Systems, Inc. FOZ Class II 1995-09-01

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