meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
2004-12-06

Clearances · page 54 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K040865 AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER Aesculap FRG Class II 2004-12-06
K043256 HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 Hospira, Inc. MEA Class II 2004-12-06
K042862 BD ONECATH Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 2004-12-03
K043019 VASCULAR SOLUTIONS SCLERO-KIT Vascular Solutions, Inc. FMI Class II 2004-12-01
K041913 POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE Pt. Medisafe Technologies LZA Class I 2004-12-01
K042547 DRAGON HEART PISTON SYRINGE Dragon Heart Medical Devices Co., Ltd. FMF Class II 2004-12-01
K043000 MODIFICATION TO D-TRONPLUS Disetronic Medical Systems AG LZG Class II 2004-12-01
K040985 PUMP CONNECTIVITY INTERFACE Baxter Healthcare Corp FRN Class II 2004-11-30
K030901 MEDTRADE PRODICT'S SOOTHING GEL PATCH Medtrade Products , Ltd. NTC Class I 2004-11-26
K042618 LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) La Glove (M) Sdn. Bhd. FMC Class I 2004-11-26
K042936 SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE Baxter Healthcare Corp FPA Class II 2004-11-26
K042653 PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP Pack & Proper Co., Ltd. FLL Class II 2004-11-26
K041861 NEXUS INTRAVENOUS TUBING SETS (NIVTS) Nexus Medical, LLC FPA Class II 2004-11-26
K042645 POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING Qingdao Bestex Rubber & Plastic Products Co., Ltd. LYY Class I 2004-11-26
K042491 BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER Becton, Dickinson & CO LJS Class II 2004-11-22
K042314 SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE Biogen FMF Class II 2004-11-22
K042906 AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 Amplife Corporation FLL Class II 2004-11-19
K042580 TIDI BRAND STERILIZATION WRAP Banta Healthcare Group, Ltd. FRG Class II 2004-11-17
K042830 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES Grand Work Plastic Products Co., Ltd. LYZ Class I 2004-11-17
K042980 HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE Hospira, Inc. FRN Class II 2004-11-17
K042557 INNOJECT AUTO-INJECTOR Innoject, Inc. KZH Class II 2004-11-08
K042228 BEELINE MOTIV, PROPOLIS, PCA Mckinley, Inc. FRN Class II 2004-11-08
K041239 GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 Genesis Medical Technology, Inc. KZE Class II 2004-11-08
K042120 POWDERED VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Manful Light Industrial Products Co., LYZ Class I 2004-11-04
K042119 POWDER-FREE VINYL PATIENT EXAMINTION GLOVES Shijiazhuang Manful Light Industrial Products Co., LYZ Class I 2004-11-03
K041088 TRIFUSION, MODEL 0609190/0659350 C.R. Bard, Inc. LJS Class II 2004-11-01
K041490 IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING B.Braun Medical, Inc. FPA Class II 2004-10-29
K042934 1BD SOLOSHOT IX SYRINGE Becton, Dickinson & CO FMF Class II 2004-10-28
K040223 POLYVAC INSTRUMENT DELIVERY SYSTEM Symmetry Medical USA, Inc. KCT Class II 2004-10-22
K042693 IV ADMINISTRATION SET B400 SP Codan US Corp. FPA Class II 2004-10-21
K042800 LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc. MEA Class II 2004-10-18
K042627 EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 Mesure Technology Co., Ltd. FLL Class II 2004-10-18
K042712 TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM Safety Syringes, Inc. MEG Class II 2004-10-15
K042063 PRESS TACK NEEDLE Asia-Med GmbH & Co. Kg. - Werk Suhl MQX Class II 2004-10-14
K041222 PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET B.Braun Medical, Inc. LHI Class II 2004-10-14
K042405 PAINPUMP1; PAINPUMP2 Stryker Corp. FRN Class II 2004-10-14
DEN040007 VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER Digital Angel Corporation NRV Class II 2004-10-12
K042410 BAXJECT II Baxter Healthcare Corp LHI Class II 2004-10-08
K042172 CLEO 90 INFUSION SET Smiths Medical MD, Inc. FPA Class II 2004-10-07
K042609 HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE Hospira, Inc. FRN Class II 2004-10-06
K033589 BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR Micromedics, Inc. FMF Class II 2004-10-04
K041919 PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606 Clinico FPA Class II 2004-10-04
K041714 E-PAIN CARE Breg, Inc. FRN Class II 2004-10-01
K042062 PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE Bard Peripheral Vascular, Inc. KCT Class II 2004-09-30
K042226 SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY Syntex Healthcare Products Co., Ltd. LZA Class I 2004-09-30
K042575 AMPLIFE DIGITAL CLINICAL THERMOMETER Amplife Corporation FLL Class II 2004-09-30
K041830 MAGELLAN RATIO DISPENSER KIT Medtronic Perfusion Systems FMF Class II 2004-09-29
K042426 TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN) Taiject Medical Device Co., Ltd. MEG Class II 2004-09-22
K042122 SMARTINFUSER PAINPUMP Precise Medical Products MEB Class II 2004-09-22
K041779 NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L Nipro Medical Corp. FMG Class II 2004-09-21
K042378 NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE Shijiazhuang Tillotson Rubber Products Co., Ltd. LZA Class I 2004-09-20
K042145 READY-HEAT BLANKET Techtrade, LLC KME Class I 2004-09-17
K040533 EZ HUBER SAFETY INFUSION SET Pfm Medical, Inc. FPA Class II 2004-09-17
K042085 CRONO F Cane S.R.L. FRN Class II 2004-09-17
K040377 RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES Radiant Innovation, Inc. FLL Class II 2004-09-16
K042238 CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES Seal Polymer Industries Bhd. LZA Class I 2004-09-16
K041991 ASPIREX - BONE MARROW ASPIRATE KIT Isotis Orthobiologics, Inc. FMF Class II 2004-09-16
K042214 POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES Shandong Perfect Plastic Co., Ltd. LYZ Class I 2004-09-15
K041692 INFRARED EAR THERMOMETER, ET-100 SERIES Hangzhou Hua'An Medical & Health Instruments Co., FLL Class II 2004-09-13
K041784 RAVEN PROTEST - EO Raven Biological Laboratories, Inc. FRC Class II 2004-09-13
K041694 DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER Hangzhou Hua'An Medical & Health Instruments Co., FLL Class II 2004-09-13
K041941 SAFE T RETRACTABLE BLOOD COLLECTION DEVICE Safe T Medical Devices, Ltd. FMI Class II 2004-09-13
K042202 TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502 Oriental System Technology, Inc. FLL Class II 2004-09-10
K040901 STERITEC EMU-GRAPH, MODEL NO. CI 131/US Steritec Products, Inc. JOJ Class II 2004-09-09
K042213 PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES Shandong Perfect Plastic Co., Ltd. LYZ Class I 2004-09-09
K041468 PREMICATH, 1261.205 Vygon Corp. LJS Class II 2004-09-09
K041516 DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9 Vega Technologies, Inc. FLL Class II 2004-09-08
K042013 DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F Mesure Technology Co., Ltd. FLL Class II 2004-09-08
K042234 MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET Specialty Health Products, Inc. FPA Class II 2004-09-08
K041844 ALL SAFE HUBER SAFETY INFUSION SETS Nexus Medical, LLC FPA Class II 2004-09-03
K042247 SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE Shijiazhuang Hongxiang Plastics Products Co., Ltd. LYZ Class I 2004-09-02
K042182 Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 Icu Medical, Inc. FPA Class II 2004-09-01
K042246 MULTI-DRIP INFUSION CATHETER Advanced Infusion, Inc. MEB Class II 2004-08-31
K041379 PRE-POWDERED VINYL EXAM GLOVES Shijiazhuang Wally Plastics Co., Ltd. LYZ Class I 2004-08-31
K042101 CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES Seal Polymer Industries Bhd. LZA Class I 2004-08-27
K042126 PICC Arrow Intl., Inc. LJS Class II 2004-08-27
K041585 AUTOFUSER AMBULATORY INFUSION PUMP Algos, LC MEB Class II 2004-08-26
K040580 AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR D.Y. Instrument, Inc. NRW Class II 2004-08-26
K042121 SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY Sigma Intl. FRN Class II 2004-08-26
K042061 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE Becton Dickinson NGT Class II 2004-08-26
K042081 PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc. FRN Class II 2004-08-24
K041845 NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4 Nexus Medical, LLC FPA Class II 2004-08-24
K041976 SMITH & NEPHEW GRAFT DELIVERY SYSTEM Smith & Nephew, Inc. FMF Class II 2004-08-23
K041945 POWDER-FREE BLUE VINYL EXAM GLOVES Glormed Intl., Inc. LYZ Class I 2004-08-20
K041276 POWDER-FREE NITRILE EXAMINATION GLOVES Shanghai Motex Healthcare Co., Ltd. LZA Class I 2004-08-20
K041848 POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR Pt. Smartglove Indonesia LZA Class I 2004-08-20
K031152 PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) Propper Mfg. Co., Inc. JOJ Class II 2004-08-17
K040108 OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN Est International Corporation LYZ Class I 2004-08-17
K040792 POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) Pt. Smartglove Indonesia LYY Class I 2004-08-12
K041503 HOVERJACK AIR PATIENT LIFT DEVICE D.T. Davis Enterprises , Ltd. FNG Class II 2004-08-12
K033843 SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING Cook, Inc. FOZ Class II 2004-08-12
K032192 PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V Tuttnauer U.S.A Co, Ltd. FLE Class II 2004-08-12
K040710 TEGO NEEDLE FREE ACCESS ACCESS DEVICE Icu Medical, Inc. FPA Class II 2004-08-11
K041386 RAVEN PROTEST - STEAM Raven Biological Laboratories, Inc. FRC Class II 2004-08-09
K042028 VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE Zibo Borui Plastic & Rubber Products Co., Ltd. LYZ Class I 2004-08-09
K041504 HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01 Haemacure Corp. FMF Class II 2004-08-06
K041691 CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT West Pharmaceutical Services, Inc. LHI Class II 2004-08-05
K041415 EVA TPN CONTAINER B.Braun Medical, Inc. KPE Class II 2004-08-04
K041970 BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML Biotop Technology Co., Ltd. MEG Class II 2004-08-03
K041996 NIGHTFORM Plastic Surgery Solutions, LLC FRP Class I 2004-08-03

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