meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
30
Latest Decision
2004-08-02

Clearances · page 55 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K033222 OLYMPUS STERILIZATION TRAYS Olympus Winter & Ibe GmbH KCT Class II 2004-08-02
K041399 HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE Smiths Medical Asd, Inc. FMI Class II 2004-07-28
K041410 PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 Icu Medical, Inc. FPA Class II 2004-07-28
K040682 SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE Grand Work Plastic Products Co., Ltd. LYZ Class I 2004-07-28
K041420 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT AngioDynamics, Inc. LJS Class II 2004-07-26
K041232 GETTIG UNIVERSAL VIAL ACCESS PIN Gettig Pharmaceutical Instrument Co. LHI Class II 2004-07-22
K041646 THERMOTEK Q5 Saat , Ltd. FLL Class II 2004-07-22
K041345 PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES Medix, Inc. FOZ Class II 2004-07-22
K041318 MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP Medtronic Minimed LZG Class II 2004-07-19
K041317 MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP Medtronic Minimed LZG Class II 2004-07-19
K041564 Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 Bioject Medical Technologies, Inc. LHI Class II 2004-07-16
K041178 EMPOWER TRANSFER SET, (CAT. NO. 7725) E-Z-Em, Inc. FPK Class II 2004-07-16
K041344 OPEN BORE SYRINGE Isotis NV FMF Class II 2004-07-16
K041042 SPLIT SEPTUM INJECTION SITES Fresenius Medical Care North America FPA Class II 2004-07-16
K041745 VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR Arista Latindo Industrial Ltd. P.T LYZ Class I 2004-07-15
K041084 CLIP-ON SPACER 20%; 40%; 50% Serono, Inc. FMF Class II 2004-07-15
K041225 SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED Grand Work Plastic Products Co., Ltd. LYZ Class I 2004-07-15
K033448 ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER John Mfg., Ltd. FRA Class II 2004-07-12
K041153 SHARPSAWAY II LOCKING DISPOSABLE CUP Arrow Intl., Inc. FMI Class II 2004-07-12
K033739 PHYSICIAN INDUSTRIES' DURAMETER SYRINGE Physician Industries, Inc. FMF Class II 2004-07-12
K041738 BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) Baxter Healthcare Corporation FRN Class II 2004-07-09
K041391 FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES Hartalega Sdn Bhd LZA Class I 2004-07-09
K041414 CRONO AND CRONO, MODEL 30 Cane S.R.L. FRN Class II 2004-07-08
K040841 POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) Medline Industries, Inc. LZA Class I 2004-07-08
K041241 MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 Alaris Medical Systems, Inc. FRN Class II 2004-07-06
K041325 DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE Est International Corporation LYZ Class I 2004-07-02
K041004 ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE) Purna Bina Sdn Bhd LYY Class I 2004-07-02
K032438 MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE Tyco Healthcare NGT Class II 2004-06-30
K041550 HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Abbott Laboratories FRN Class II 2004-06-30
K041545 CONTACT DETACH Unomedical A/S FPA Class II 2004-06-30
K041191 COLLEAGUE VOLUMETRIC INFUSION PUMPS Baxter Healthcare Corp FRN Class II 2004-06-25
K032948 ELASTIC SKIN LIQUID BANDAGE Medpak, LLC KMF Class I 2004-06-25
K041017 SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK Spsmedical Supply Corp. JOJ Class II 2004-06-25
K033533 POWDER FREE LATEX EXAMINATION GLOVES Apl International Incorporated Limited LYY Class I 2004-06-24
K041280 HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 Felton International, Inc. KZE Class II 2004-06-24
K041590 AUTODETECT SYRINGE Indigo Orb, Inc. FMF Class II 2004-06-23
K040853 PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 International Hospital Supply Co. LBI Class II 2004-06-21
K023956 THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F Mesure Technology Co., Ltd. FLL Class II 2004-06-17
K040967 DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd. LYZ Class I 2004-06-16
K041041 NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES Shanghai Foremost Plastic Industrial Co., Ltd. LYZ Class I 2004-06-08
K041179 MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR Medegen Medical Manufacturing Services, Inc. FPA Class II 2004-06-04
K040149 PSI-TEC PERISTALTIC INFILTRATION PUMP Byron Medical FRN Class II 2004-06-03
K032767 LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES Lily Medical Supplies Co., Ltd. FPA Class II 2004-06-03
K040681 SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE Grand Work Plastic Products Co., Ltd. LYZ Class I 2004-06-03
K040071 ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN Elite International, Inc. LYZ Class I 2004-06-03
K040791 POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) Pt. Smartglove Indonesia LZA Class I 2004-06-03
K033790 THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES Tecnimed S.R.L. FLL Class II 2004-06-03
K041188 GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED Grand Work Plastic Products Co., Ltd. LYZ Class I 2004-06-01
K031738 SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER Smiths Medical MD, Inc. LZG Class II 2004-05-27
K032914 MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS Raven Biological Laboratories, Inc. FRC Class II 2004-05-25
K040337 I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) I-Flow Corp. MEB Class II 2004-05-24
K041152 THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A Applied Diabetes Research, Inc. FRN Class II 2004-05-24
K040676 MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 Medtronic Minimed LZG Class II 2004-05-21
K040957 NOA III ENTERAL NUTRITION PUMP Caesarea Medical Electronics , Ltd. LZH Class II 2004-05-21
K040636 CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET Smiths Medical MD, Inc. FPA Class II 2004-05-19
K032517 MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE Medsafe Technologies, LLC MEG Class II 2004-05-18
K040779 RESTORE WOUND CLEANSER Hollister, Inc. KMF Class I 2004-05-17
K040406 POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) Shun Thai Rubber Gloves Industry Public Co., Ltd. LYY Class I 2004-05-14
K041056 10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88 Mesure Technology Co., Ltd. FLL Class II 2004-05-12
K032016 DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT Wrp Specialty Products Sdn. Bhd. LYY Class I 2004-05-11
K032747 BIOTOP DJT-A SAFETY SYRINGE Biotop Technology Co., Ltd. MEG Class II 2004-05-11
K041060 E-Z LUBRICATING JELLY Chester Labs, Inc. KMJ Class I 2004-05-07
K033789 LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING Cardinalhealth LZC Class I 2004-05-07
K041099 MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP Spsmedical Supply Corp. FRC Class II 2004-05-06
K040196 KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS Tyco Healthcare/Kendall LZH Class II 2004-05-05
K040936 PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE Leda Co., Ltd. FQM Class I 2004-05-03
K040427 FIBREX CATHETER PATENCY DEVICE Medical Device Technologies, Inc. FOZ Class II 2004-05-03
K033077 EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021 Metatech Co., Ltd. FLL Class II 2004-04-30
K040899 MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP Medex, Inc. FRN Class II 2004-04-30
K030604 PERFECT SAFETY SYRINGE Perfect Medical Industry Co., Ltd. MEG Class II 2004-04-30
K040645 DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI Wrp Asia Pacific Sdn. Bhd. LYY Class I 2004-04-28
K040702 SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE Grand Work Plastic Products Co., Ltd. LYZ Class I 2004-04-27
K040054 BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE Theodore Barash FQM Class I 2004-04-27
K040607 MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES Pt. Medisafe Technologies LZA Class I 2004-04-22
K040545 OTTER SAFETY SYRINGE Otter (China) Technology Co., Ltd. MEG Class II 2004-04-22
K033534 VITALSENSE Mini-Mitter Co., Inc. FLL Class II 2004-04-22
K040910 INFANT INCUBATOR, MODEL CHS-I1000 Choong Wae Medical Corp. FMZ Class II 2004-04-21
K040828 DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES Zibo Borui Plastic & Rubber Products Co., Ltd. LYZ Class I 2004-04-19
K040707 PACKAGING TRAY AND COMPONENTS Vygon Us, LLC FRG Class II 2004-04-16
K032976 BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 Biovalve Technologies, Inc. KZE Class II 2004-04-16
K040068 BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM Ohmeda Medical FMZ Class II 2004-04-16
K040793 FELCARE POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES Hl Rubber Products Sdn Bhd LYY Class I 2004-04-14
K033290 TALON INFUSION SET, MODEL IP XXXX Icu Medical, Inc. FPA Class II 2004-04-12
K032848 MEDSAFE SYSTEM INSERTER Medsolve Technologies, LLC KZH Class II 2004-04-12
K040061 MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C Medtronic Minimed FRN Class II 2004-04-08
K040385 MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900 Quest Medical, Inc. FPA Class II 2004-04-07
K040752 DOSI-FUSER Leventon, S.A. MEB Class II 2004-04-07
K040105 YUE PFONG SAFETY SYRINGE (3ML) Yue Pfong International Industrial Co., Ltd. MEG Class II 2004-04-07
K040742 MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE Advanced Sterilization Products JOJ Class II 2004-04-02
K040633 CLICK-ON Unomedical A/S FPA Class II 2004-04-01
K032445 THE ULTRA SYSTEM Promedica, Inc. KCT Class II 2004-03-29
K040527 LOW PROFILE LUTHER SAFETY HUBER Luther Needlesafe Products, Inc. FPA Class II 2004-03-26
K040634 ROBERTSITE VIAL ADAPTER, MODEL 245700021 Halkey-Roberts Corp. LHI Class II 2004-03-23
K040448 GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM Rosner-Mautby Meditrade(Thailand) , Ltd. LYY Class I 2004-03-23
K040531 TERUMO SURGUARD2 SAFETY NEEDLE Terumo Medical Corp. FMI Class II 2004-03-23
K040532 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd. LYZ Class I 2004-03-23
K032292 BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX Bioteque Corp. FOZ Class II 2004-03-22
K033389 POWERPICC CATHETERS, MODELS 3175155, 3175135 C.R. Bard, Inc. LJS Class II 2004-03-19
K040036 INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905 Inviro Medical MEG Class II 2004-03-18
K033208 IVY DEVICES INC. IV/MEDICAL LINE STABILIZER Ivy Devices, Inc. FPA Class II 2004-03-18

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