meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
26
Latest Decision
2003-03-21

Clearances · page 59 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K030331 ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM Perusahaan Getah Asas Sdn. Bhd. LYY Class I 2003-03-21
K030333 LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM Perusahaan Getah Asas Sdn. Bhd. LYY Class I 2003-03-21
K030853 STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI Case Medical, Inc. FRG Class II 2003-03-21
K030149 MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9 Avail Medical Products, Inc. FPA Class II 2003-03-20
K023189 VISTA BASIC WITH FM SYSTEM B.Braun Medical, Inc. FRN Class II 2003-03-20
K030200 POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE Kaohsiung Brothers Products Corp. LYZ Class I 2003-03-20
K024190 FENESTRATED INFUSION CATHETER Promedic, Inc. FRN Class II 2003-03-17
K030467 GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET Iv Medical, Inc. FPA Class II 2003-03-14
K023693 MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 Airex, Inc. FRF Class II 2003-03-12
K023074 IMBIBE BONE MARROW ASPIRATION SYRINGE Orthovita, Inc. FMF Class II 2003-03-11
K030164 NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN Yty Industry (Manjung) Sdn Bhd LYY Class I 2003-03-07
K030483 SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES Emerald Medical, Inc. LYZ Class I 2003-03-06
K030484 SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES Emerald Medical, Inc. LYZ Class I 2003-03-06
K030075 NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED) Best Manufacturing Company-Distribution Center LZA Class I 2003-03-05
K023025 SELF SEAL STERILIZATION POUCH Granton Medical , Ltd. FRG Class II 2003-03-04
K030335 ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED Perusahaan Getah Asas Sdn. Bhd. LZA Class I 2003-03-03
K023348 MIDMARK M9 ULTRACLAVE STEAM STERILIZER Midmark Corp. FLE Class II 2003-03-03
K024338 POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE General Gloves Corp. LYZ Class I 2003-03-03
K023083 SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 Mettler Electronics Corp. FRN Class II 2003-02-28
K030406 NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR Pt. Smartglove Indonesia LZA Class I 2003-02-27
K024079 ALIBI BIOLOGICAL INDICATOR, MODEL WS Arden Laboratories, Incorporated FRC Class II 2003-02-27
K023973 AUTOMED 3200 INFUSION PUMP Help Technologies FRN Class II 2003-02-27
K024216 TOP GLOVE VINYL EXAMINATION GLOVE Top Glove (Zhangjiagang) Co. , Ltd. LYZ Class I 2003-02-27
K030112 POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB Pt. Smartglove Indonesia LYY Class I 2003-02-27
K030324 RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES Radiant Innovation, Inc. FLL Class II 2003-02-27
K030004 0.55% ORTH-PHTHALALDEHYDE SOLUTION Advanced Sterilization Products MED Class II 2003-02-27
K030246 VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072 Victus, Inc. FPA Class II 2003-02-26
K023917 WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR Kawasumi Laboratories, Inc. FPA Class II 2003-02-26
K030299 TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX Oriental System Technology, Inc. FLL Class II 2003-02-25
K030190 CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES Suzhou Sen Sen Medical Supplies , Ltd. MQX Class II 2003-02-21
K024249 TERUMO SURGUARD SAFETY SYRINGE Terumo Medical Corp. MEG Class II 2003-02-21
K030361 JASUN, MODELS DT-01F AND DT-11F Hangzhou Hua'An Medical & Health Instruments Co., FLL Class II 2003-02-21
K024052 MERIT MEDICAL 1-ML SYRINGE Merit Medical Systems, Inc. FMF Class II 2003-02-21
K022814 MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED) Pt. Smartglove Indonesia LZA Class I 2003-02-19
K030148 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR Shanghai Palomar Mountain Industries, Inc. LYZ Class I 2003-02-19
K030137 MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9 Avail Medical Products, Inc. FPA Class II 2003-02-19
K024363 NEXUS INJECTION SITE (NIS), MODEL NIS-1 Nexus Medical, LLC FPA Class II 2003-02-19
K030157 POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM Wrp Asia Pacific Sdn. Bhd. LYY Class I 2003-02-19
K023787 TAI-CHI AND MASTER ACUPUNCTURE NEEDLES Lhasa Medical, Inc. MQX Class II 2003-02-14
K023974 ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES Top Glove Sdn. Bhd. LYY Class I 2003-02-13
K022815 MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX Pt. Smartglove Indonesia LYY Class I 2003-02-13
K023072 POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR Arista Latindo Industrial Ltd. P.T LZA Class I 2003-02-13
K021580 OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05 LeMaitre Vascular, Inc. LJT Class II 2003-02-12
K023910 STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES Sanrea Healthcare Private Limited LYY Class I 2003-02-11
K023915 STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES Sanrea Healthcare Private Limited LYY Class I 2003-02-11
K030255 SILICONE DUAL LUMEN RADPICC CATHETERS C.R. Bard, Inc. LJS Class II 2003-02-07
K023890 PREPARE CARTRIDGE Appro Healthcare, Inc. MRZ Class II 2003-02-07
K030126 NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN 600,610,620,630,602,612,622,632, TS 600,6 Norm Pacific Automation Corp. FLL Class II 2003-02-07
K023863 AUTOMED 3000 INFUSION PUMP Help Technologies FRN Class II 2003-02-07
K022816 W & H LISA STEAM STERILIZER A-Dec, Inc. FLE Class II 2003-02-07
K023752 BD INTEGRA SYRINGE Bd FMF Class II 2003-02-07
K023830 AIROCIDE TI02 Kes Science & Technology, Inc. FRA Class II 2003-02-04
K023510 TRUTEK SELECT MODEL TT-1001 Trutek, Inc. FLL Class II 2003-02-04
K023715 STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM Starmatrix Sdn Bhd LYY Class I 2003-02-04
K024355 EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE Yty Industry (Manjung) Sdn Bhd LYY Class I 2003-02-03
K024016 POWDERED VINYL EXAMINATION GLOVES Top Glove (Zhangjiagang) Co. , Ltd. LYZ Class I 2003-02-03
K024174 NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES General Gloves Corp. LYZ Class I 2003-01-28
K030083 VAXCEL WITH PASV PORT Boston Scientific Corp LJT Class II 2003-01-28
K024373 MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5 Elltec Co., Ltd. LGZ Class II 2003-01-28
K024081 DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR Safehealth Medical Supply Corp. LYZ Class I 2003-01-28
K030002 LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT. Abbott Laboratories FPA Class II 2003-01-27
K023978 NITRILE EXAMINATION GLOVES, POWDER FREE Starmatrix Sdn Bhd LZA Class I 2003-01-24
K023977 PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM Starmatrix Sdn Bhd LYY Class I 2003-01-24
K023979 NITRILE EXAMINATION GLOVES, PRE-POWDERED Starmatrix Sdn Bhd LZA Class I 2003-01-24
K023866 POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES Kl-Kepong Rubber Products Sdn. Bhd. LYY Class I 2003-01-24
K020586 GOOD LUBRICATIONS Biofilm, Inc. KMJ Class I 2003-01-24
K023826 SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR Syntex Healthcare Products Co., Ltd. LYY Class I 2003-01-24
K011754 EXEL SECURETOUCH PTP SYRINGE Exelint Intl. Co. MEG Class II 2003-01-22
K024018 AVANT GUARDIAN 101 Avant Medical Corporation KZE Class II 2003-01-17
K024056 SURESET 3.0 ML RESERVOIR, MODEL 24-103 Applied Diabetes Research, Incorporated FRN Class II 2003-01-17
K023653 MAXONE IV FLUID/BLOOD WARMER, MODEL 102 Automatic Medical Technologies, Inc. LGZ Class II 2003-01-17
K023490 DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL Wrp Asia Pacific Sdn. Bhd. LYY Class I 2003-01-16
K024184 POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED Perusahaan Getah Asas Sdn. Bhd. LZA Class I 2003-01-14
K024239 CHEMO DISPENSING PIN, MODEL 12495 Abbott Laboratories LHI Class II 2003-01-13
K023163 LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020 Medlogic Global Limited KMF Class I 2003-01-13
K024083 GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR Supermax Glove Manufacturing Sdn Bhd LZA Class I 2003-01-10
K024292 MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM Allegiance Healthcare Corp. LYY Class I 2003-01-09
K024112 BD INSULIN SYRINGE Becton, Dickinson & CO FMF Class II 2003-01-09
K023728 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR Canopus Medical Supply Co., Ltd. LYZ Class I 2003-01-07
K021130 SPECATH CENTRAL VENOUS CATHETER KITS Special Medical Co. , Ltd. FOZ Class II 2003-01-07
K024154 SHANGHAI HUAMAO POWDER-FREE YELLOW VINYL EXAM GLOVES Shanghai Huamao Gloves Co., Ltd. LYZ Class I 2003-01-06
K024084 ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 Abbott Laboratories FRN Class II 2002-12-31
K023769 PREPARE ADMINISTRATION SET Appro Healthcare, Inc. FPA Class II 2002-12-30
K022091 BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES Tangshan Zhonghong Pulin Group Co., Ltd. LYZ Class I 2002-12-30
K024109 BD ULTRA-FINE III PEN NEEDLE Becton, Dickinson & CO FMI Class II 2002-12-30
K024106 NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM Siam Sempermed Corp., Ltd. LYY Class I 2002-12-20
K024121 NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM Siam Sempermed Corp., Ltd. LYY Class I 2002-12-20
K023883 HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO I-Flow Corp. MEB Class II 2002-12-20
K023264 MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 Alaris Medical Systems, Inc. FRN Class II 2002-12-19
K024026 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR Shanghai PM Plastics Enterise Co., Ltd. LYZ Class I 2002-12-18
K024102 DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM Allegiance Healthcare Corp. LYY Class I 2002-12-18
K023374 GROSHONG NXT DUAL LUMEN PICC CATHETERS C.R. Bard, Inc. LJS Class II 2002-12-18
K023595 BURETTE-IN LINE (150 ML) Tuta Healthcare Pty Limited FPA Class II 2002-12-18
K023271 TERUMO SYRINGE WITH/WITHOUT NEEDLE Terumo Medical Corp. FMF Class II 2002-12-18
K024025 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR Kossan Latex Industries(M)Sdn Bhd LZA Class I 2002-12-18
K023702 POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE Ningbo Tianshun Rubber Products Co., Ltd. LZA Class I 2002-12-18
K023560 ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED Shanghai Palomar Mountain Industries, Inc. LYZ Class I 2002-12-17
K023539 STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW Valumed LHI Class II 2002-12-17
K023827 PARAGON INFUSION SYSTEM WITH BOLUS I-Flow Corp. FRN Class II 2002-12-13
K023500 DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306 Innovatech, Inc. FLL Class II 2002-12-13

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