meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
28
Latest Decision
2003-10-24

Clearances · page 57 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K031503 AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER Avita Corporation FLL Class II 2003-10-24
K031928 BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT) Braun GmbH FLL Class II 2003-10-24
K033069 DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205 Tenghi Co., Ltd. FLL Class II 2003-10-24
K031750 SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE Kimberly-Clark Corp. LYZ Class I 2003-10-24
K032164 DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 Medtronic Minimed LZG Class II 2003-10-23
K032714 CARDICARE MODEL MT-301F & MT-301C Lumiscope Co., Inc. FLL Class II 2003-10-22
K032374 POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED Perusahaan Getah Asas Sdn. Bhd. LZC Class I 2003-10-22
K032801 MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR Albert Browne , Ltd. JOJ Class II 2003-10-17
K032745 SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES Shanghai Giantmax Plastic Product Corp. LYZ Class I 2003-10-17
K032746 SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES Shanghai Giantmax Plastic Product Corp. LYZ Class I 2003-10-17
K032257 MODEL IR 1200 INSULIN PUMP Animas Corp. LZG Class II 2003-10-16
K031012 ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK 3M Company FRC Class II 2003-10-16
K033099 ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 Applied Diabetes Research, Incorporated FPA Class II 2003-10-16
K031335 POWDER FREE LATEX EXAM GLOVES Tan Sin Lian Industries Sdn. Bhd. LYY Class I 2003-10-16
K032792 PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW Shanghai Jiawang Industrial Co. , Ltd. LYZ Class I 2003-10-15
K032201 RUBBERCARE POWDERED LATEX EXAMINATION GLOVES Perusahaan Pelindung Getah (M) Sdn Bhd LYY Class I 2003-10-10
K032071 POWDER FREE VINYL EXAMINATION GLOVE Shanghai Foremost Plastic Industrial Co., Ltd. LYZ Class I 2003-10-10
K032854 UNOMEDICAL MONICA INFUSION SET Unomedical A/S FPA Class II 2003-10-09
K032789 REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 American I.V. Products, Inc. FRN Class II 2003-10-09
K033039 MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS Mckinley, Inc. MEB Class II 2003-10-07
K031909 BETEC RETRACTABLE SAFETY SYRINGE (5ML) Betec Medical Science Co., Ltd. MEG Class II 2003-10-07
K032323 BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW Long First (Xiamen) Plastics Co., Ltd. LYZ Class I 2003-10-07
K031263 3M LIQUID BANDAGE, MODEL 120-LB 3M Company KMF Class I 2003-10-07
K031386 LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX Lalan Gloves (Pvt) , Ltd. LYY Class I 2003-10-06
K032668 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES Kingswell International, Inc. LYZ Class I 2003-10-06
K032630 DISPOSABLE POWDER FREE VINYL EXAM GLOVES Kingswell International, Inc. LYZ Class I 2003-10-03
K032616 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES Elite International, Inc. LYZ Class I 2003-10-02
K032723 BIOSIGN STEAM-24 BIOLOGICAL INDICATOR Getinge USA, Inc. FRC Class II 2003-10-01
K024133 CLS-2000 UNIT Dentsply Intl. FLE Class II 2003-10-01
K032247 U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE U.S. Technologies, Inc. MEG Class II 2003-09-30
K032780 INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC Inviro Medical MEG Class II 2003-09-24
K032642 BEELINE SYSTEM Mckinley, Inc. FRN Class II 2003-09-23
K032771 MEDRAD CONTINUUM MR INFUSION SYSTEM Medrad, Inc. FRN Class II 2003-09-23
K031944 VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR Arista Latindo Industrial Ltd. P.T LZA Class I 2003-09-23
K032364 MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932) Microlife Intellectual Property GmbH FLL Class II 2003-09-23
K032778 LARGE VOLUME FLUID RESERVOIR Belmont Instrument Corp. LGZ Class II 2003-09-22
K032674 BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 Belmont Instrument Corp. LGZ Class II 2003-09-16
K032754 VORTEX MP Horizon Medical Products, Inc. LJT Class II 2003-09-12
K032150 SAFETY-MULTIFLY Sarstedt, Inc. FPA Class II 2003-09-12
K032393 INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) Elcam Medical Acal FMG Class II 2003-09-12
K032658 MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER Microlife Intellectual Property GmbH FLL Class II 2003-09-11
K032600 VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 Boston Scientific Corp LJT Class II 2003-09-09
K032557 TRIUMPH VTX WITH LIFEVALVE CATHETER Horizon Medical Products, Inc. LJT Class II 2003-09-09
K032233 MEDLEY PCA MODULE, MODEL 8120 Alaris Medical Systems, Inc. MEA Class II 2003-09-09
K032528 BD ECLIPSE BIFURCATED NEEDLE Becton, Dickinson & CO SCL Class II 2003-09-09
K021471 MARQUETTE HUBER TRAP SAFETY INFUSION SET Marquette Medical, Inc. FPA Class II 2003-09-08
K031108 SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE Shijiazhuang Great Vision Plastic Products Co., LT LYZ Class I 2003-09-08
K032549 MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES Matang Mfg. Sdn. Bhd. LZA Class I 2003-09-08
K020424 V SET Hennig Enterprises Europe Srl FPA Class II 2003-08-29
K020419 V SET P.T. Greenleaf FPA Class II 2003-08-29
K032432 BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER Busse Hospital Disposables, Inc. FMJ Class II 2003-08-28
K032293 NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PROTEIN Sgmp Co., Ltd. LYY Class I 2003-08-28
K032294 NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING Sgmp Co., Ltd. LYY Class I 2003-08-28
K032325 JOBST TRAVEL SOCKS Bsn-Jobst, Inc. DWL Class II 2003-08-28
K021161 TSO3 OZONE CHEMICAL INDICATOR Technologies of Sterilization With Oxone, Tso3, Inc. JOJ Class II 2003-08-27
K032236 DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR Est International Corporation LYZ Class I 2003-08-26
K020875 TSO3 OZONE STERILIZER, MODEL 125L Technologies of Sterilization With Oxone, Tso3, Inc. FLF Class II 2003-08-26
K032272 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR Est International Corporation LYZ Class I 2003-08-26
K032005 MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 Medtronic Minimed FRN Class II 2003-08-22
K031749 BODYGUARD INFUSION SYSTEM Caesarea Medical Electronics , Ltd. FRN Class II 2003-08-21
K031907 NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551 Norm Pacific Automation Corp. FLL Class II 2003-08-21
K030574 GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER Glustitch, Inc. KMF Class I 2003-08-21
K032375 VAXCEL PORT, MODELS 45-336 AND 45-338 Boston Scientific Corp LJT Class II 2003-08-19
K031917 MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S Medtronic Minimed FPA Class II 2003-08-19
K031566 SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 Baxter Healthcare Corp MEA Class II 2003-08-19
K032011 GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE Pt. Wrp Buana Multicorpora LZA Class I 2003-08-19
K032010 GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE Pt. Wrp Buana Multicorpora LZA Class I 2003-08-19
K032077 CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET) Seal Polymer Industries Bhd. LZA Class I 2003-08-19
K030429 STERRAD 200 STERILIZER Advanced Sterilization Products MLR Class II 2003-08-18
K030479 JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET Jms North America Corp. FOZ Class II 2003-08-18
K031157 POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED Qingdao Bestex Rubber & Plastic Products Co., Ltd. LZA Class I 2003-08-15
K031958 MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1 Microlife Intellectual Property GmbH FLL Class II 2003-08-15
K032172 DISPOSABLE POWDER FREE VINYL EXAM GLOVES Synmertex Co, Ltd. LYZ Class I 2003-08-14
K032190 DISPOSABLE POWDERED VINYL EXAM GLOVES Synmertex Co, Ltd. LYZ Class I 2003-08-14
K031600 CONDUCTION CATHETER Micor, Inc. FRN Class II 2003-08-13
K031923 ULTRASITE VALVE B.Braun Medical, Inc. FPA Class II 2003-08-11
K024293 BOWIE-DICK MINI PAK, MODEL BD 115 Steritec Products, Inc. JOJ Class II 2003-08-11
K030529 LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE Jda (Tianjin) Plastic Rubber Co., Ltd. LZA Class I 2003-08-08
K031432 KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II Hk Surgical, Inc. FRN Class II 2003-08-07
K031630 BIFURCATED ALLERGY SKIN TESTING NEEDLE Precision Medical Products, Inc. SCL Class II 2003-08-07
K031830 SAFEPRO PLUS SAFETY SYRINGE Formosa Medical Devices, Inc. MEG Class II 2003-08-05
K030219 DIGITAL TEMPERATURE MONITOR; MODEL KY-01 Kang Ying Medical Appliances, Inc. FLL Class II 2003-08-05
K031282 OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 LeMaitre Vascular, Inc. LJT Class II 2003-08-05
K031387 ISOLETTE INFANT INCUBATOR, MODEL C2000E Hill-Rom Manufacturing, Inc. FMZ Class II 2003-08-01
K031625 POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED Perusahaan Getah Asas Sdn. Bhd. LZA Class I 2003-08-01
K031768 BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED Perusahaan Getah Asas Sdn. Bhd. LZA Class I 2003-08-01
K031647 BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR Getinge USA, Inc. JOJ Class II 2003-07-29
K031861 MIX2VIAL TRANSFER DEVICE Medimop Medical Projects, Ltd. LHI Class II 2003-07-29
K032007 GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR Pt. Wrp Buana Multicorpora LYY Class I 2003-07-28
K032147 SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES Alaris Medical Systems, Inc. FRN Class II 2003-07-25
K031854 VINYL EXAM GLOVES, POWDER-FREE, YELLOW Shanghai Jiawang Industrial Co. , Ltd. LYZ Class I 2003-07-25
K031580 NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE Green Prospect Sdn Bhd LZA Class I 2003-07-25
K031394 AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE American Syringe Company FMF Class II 2003-07-25
K031500 EXCEL PRIMARY SOLUTION SET Exelint Intl. Co. FPA Class II 2003-07-25
K031581 NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROG Green Prospect Sdn Bhd LYY Class I 2003-07-24
K031390 MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 Minimed, Inc. LGZ Class II 2003-07-23
K031249 MODIFICATION TO STRYKER PAINPUMP Stryker Instruments FRN Class II 2003-07-21
K031250 DBC PRESS ACUPUNCTURE NEEDLES Lhasa Medical, Inc. MQX Class II 2003-07-15
K030830 B. BRAUN NERVE BLOCK CATHETER B.Braun Medical, Inc. MEB Class II 2003-07-15
K031844 VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 Boston Scientific Corp LJT Class II 2003-07-15

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