meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
1998-11-30

Clearances · page 75 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K982453 NON-STERILE E.P. LATEX EXAMINATION GLOVE Ansell Perry LYY Class I 1998-11-30
K983975 BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) Belmont Instrument Corp. FRN Class II 1998-11-30
K982877 MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE Matang Mfg. Sdn. Bhd. LYY Class I 1998-11-30
K982416 SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE Shun Thai Rubber Gloves Industry Co., Ltd. LYY Class I 1998-11-24
K983916 V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) Hdc Corp. FOZ Class II 1998-11-23
K983480 BPOS-IVAD STABILIZER Bpos, Inc. LJT Class II 1998-11-23
K981975 LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED Siam Sempermed Corp., Ltd. LYY Class I 1998-11-20
K982188 STERI-PAK BOWIE DICK TEST PACK Steritec Products Mfg Co, Inc. JOJ Class II 1998-11-20
K983838 ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP Abbott Laboratories FRN Class II 1998-11-20
K982946 PAINBUSTER INFUSION KIT I-Flow Corp. MEB Class II 1998-11-18
K982431 NMT SAFETY SYRINGE New Medical Technology , Ltd. MEG Class II 1998-11-18
K981853 BONE INJECTION GUN (B.I.G.) DEVICE Waismed, Ltd. FMI Class II 1998-11-17
K983135 BLOWER/MISTER Cardiothoracic Systems, Inc. FQH Class II 1998-11-13
K983554 ALLDRESS, ABSORBENT FILM DRESSING Molnlycke Health Care, Inc. KMF Class I 1998-11-10
K982435 IRRIGATION SYRINGE KIT Sub-Q, Inc. KYZ Class I 1998-11-06
K983367 QLICKSMART Handren Assoc. MMK Class II 1998-11-06
K982933 VINYL EXAMINATION GLOVES, POWDER FREE General Gloves Corp. LYZ Class I 1998-11-06
K973585 PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR Propper Mfg. Co., Inc. JOJ Class II 1998-11-06
K983585 LOW PH PHENOLIC 256 Central Solutions, Inc. LRJ Class I 1998-11-06
K982720 H-RAY Shijiazhuang Hongray Plastic Products Co., Ltd. LYZ Class I 1998-11-05
K983608 EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK Yty Industry (Manjung) Sdn Bhd LYY Class I 1998-11-05
K981064 POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES P.T. Irama Dinamika Latex LZA Class I 1998-11-05
K983612 POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES Shanghai Jiatai Plastic Products Co., Ltd. LYZ Class I 1998-11-05
K983494 VINYL EXAM GLOVES, POWDER FREE Glormed Intl., Inc. LYZ Class I 1998-11-05
K982838 CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 Sims Deltec, Inc. FRN Class II 1998-11-04
K983294 ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 Baxter Healthcare Corp KPE Class II 1998-11-03
K982611 UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE) Uniject Gloves Pcl LYY Class I 1998-11-02
K981600 LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED Young Innovations, LLC Dba Plak Smacker LYY Class I 1998-11-02
K982985 CITREX HOSPITAL SPRAY DISINFECTANT Caltech Industries, Inc. LRJ Class I 1998-11-02
K982839 CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 Sims Deltec, Inc. MEA Class II 1998-11-02
K983619 BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER Barchens Co. FLL Class II 1998-11-02
K982836 CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM Sims Deltec, Inc. FRN Class II 1998-11-02
K983067 FINE-JECT Henke Sass Wolf of America, Inc. FMI Class II 1998-10-30
K983207 SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Great Eagle Plastic Products Co., Ltd. LYZ Class I 1998-10-30
K982131 NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE Ansell Edmont Industrial, Inc. LZA Class I 1998-10-29
K981497 STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS Steritec Products Mfg Co, Inc. FRC Class II 1998-10-29
K982541 VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 Becton Dickinson Vacutainer Systems FMI Class II 1998-10-28
K982893 3M TEGASORB HYDROCOLLOID DRESSING 3M Company KMF Class I 1998-10-26
K982892 3M TEGASORB THIN HYDROCOLLOID DRESSING 3M Company KMF Class I 1998-10-26
K982818 HOSPAL TIPSTOP Gambro Healthcare KMF Class I 1998-10-21
K982778 BIODERM FOAM WOUND DRESSING Bioderm, Inc. KMF Class I 1998-10-21
K982888 VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM Boston Scientific Corp LJT Class II 1998-10-20
K982966 DISETRONIC PEN Disetronic Medical Systems FMF Class II 1998-10-19
K983406 SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR Banta Healthcare Group, Ltd. FLL Class II 1998-10-19
K983409 V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1 Hdc Corp. FOZ Class II 1998-10-16
K980078 PENETREASE P.T. Panca Pusaka Deli FMF Class II 1998-10-16
K982872 TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) Tg Medical Sdn. Bhd. LYY Class I 1998-10-15
K981360 VINYL PATIENT EXAMINATION GLOVE, POWDERED Glormed Intl., Inc. LYZ Class I 1998-10-15
K983175 EXTRA-CARE POWDER-FREE EXAMINATION GLOVE Ultrawin Sdn Bhd LYY Class I 1998-10-13
K981841 BREATHE EASY, MODELS AD AND CD Respiraid , Ltd. FRF Class II 1998-10-13
K982687 DISPOSABLE VINYL EXAM GLOVES, POWDERED Shanghai Antares Industries, Inc. LYZ Class I 1998-10-09
K982691 MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) Perusahaan Intan Emas Sdn. Bhd. LYY Class I 1998-10-09
K982547 STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR Steritec Products Mfg Co, Inc. JOJ Class II 1998-10-08
K983321 MICROFUSE DUAL RATE INFUSER Baxa Corp. FRN Class II 1998-10-06
K982783 VAIL 1000 ENCLOSED BED Vail Products, Inc. FNL Class II 1998-10-05
K981630 VYGON DOUBLE LUMEN UMBILICAL CATHETER Schiff & Co. FOS Class II 1998-10-01
K982020 METRON QA-IDS I.V. PUMP TESTER Metron U.S., Inc. FRN Class II 1998-09-30
K982781 DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER Thermal Waste Technology, Inc. MMK Class II 1998-09-30
K982440 NITRILE PATIENT EXAMINATION GLOVE Perusahaan Getah Asas Sdn. Bhd. LZA Class I 1998-09-30
K982704 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE Shanghai Antares Industries, Inc. LYZ Class I 1998-09-30
K981876 SYNTHETIC EXAMINATION GLOVE, POWDERED Hsing YI Plastics Processing Co, Ltd. LYZ Class I 1998-09-30
K982822 FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 Baxter Healthcare Corp CAK Class II 1998-09-30
K982806 CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE Perusahaan Getah Asas Sdn. Bhd. LYY Class I 1998-09-30
K981337 DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A Mesure Technology FLL Class II 1998-09-30
K982256 OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP Mckinley, Inc. MEB Class II 1998-09-30
K982807 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE Perusahaan Getah Asas Sdn. Bhd. LYY Class I 1998-09-30
K982842 HUMAPEN AND HUMAPEN ERGO Eli Lilly and Co. FMF Class II 1998-09-25
K971924 BLUNT SYRINGE CANNULA B.Braun Medical, Inc. FMI Class II 1998-09-25
K982507 MINI POLYURETHANE CATHETER Med Institute, Inc. LJT Class II 1998-09-16
K980566 VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER Boston Scientific Corp FOZ Class II 1998-09-14
K974188 CETYLCIDE-G Kellerandheckman MED Class II 1998-09-10
K982116 AQUACEL HYDROFIBER WOUND DRESSING Convatec, A Bristol-Myers Squibb Co. KMF Class I 1998-09-08
K982234 AL-GEN CALCIUM ALGINATE DRESSING Innovative Technologies , Ltd. KMF Class I 1998-09-08
K982102 SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY Baxter Healthcare Corp MEB Class II 1998-09-04
K982672 COLLEAGUE PUMP SYRINGE ADAPTER SET Baxter Healthcare Corp FPA Class II 1998-09-04
K981032 PIV SYSTEM Medical Solutions, Inc. LDQ 1998-09-02
K982578 QUANTI-TEST SYSTEM Panatrex, Inc. SCL Class II 1998-09-02
K974062 MEDSCI 3% GLUTARALDEHYDE Medsci, Inc. MED Class II 1998-09-02
K973593 BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5 Bridge Medical, Inc. FRN Class II 1998-08-25
K981272 ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES Electro Therapeutic Devices, Inc. MQX Class II 1998-08-24
K982587 MPS FIXED FLOW RATE SET Medical Product Specialists FPA Class II 1998-08-24
K981905 STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 Acu-Pak FOZ Class II 1998-08-18
K980109 CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER Sangstat Medical Corp. KYX Class I 1998-08-18
K980916 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM Perusahaan Getah Asas Sdn. Bhd. LYY Class I 1998-08-18
K981792 SOLUTION ADMINISTRATION SET Baxter Healthcare Corp FPA Class II 1998-08-17
K981541 CLEARSTAR ENTERAL NUTRITION PUMP Frantz Medical Development, Ltd. LZH Class II 1998-08-13
K982260 MARKWELL GAUZE SPONGE Markwell Intl., Inc. LWH Class I 1998-08-12
K981879 POWDERED NITRILE EXAMINATION GLOVES Besglove Medicare Sdn. Bhd. LZA Class I 1998-08-11
K981877 NITRILE POWDERFREE EXAMINATION GLOVES Besglove Medicare Sdn. Bhd. LZA Class I 1998-08-11
K981878 POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED) Besglove Medicare Sdn. Bhd. LZA Class I 1998-08-11
K982274 NITRILE PATIENT EXAMINATION GLOVE POWDER FREE Asia Pacific Latex Sdn Bhd LZA Class I 1998-08-11
K982286 POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) Besglove Medicare Sdn. Bhd. LYY Class I 1998-08-11
K982579 LATEX EXAMINATION GLOVES POWDER FREE Shiva Medicare , Ltd. LYY Class I 1998-08-11
K982018 LIGHT SABER ASPIRATION NEEDLE Minrad, Inc. FMF Class II 1998-08-07
K982399 DISETRONIC PENFINE INJECTION PEN NEEDLE Disetronic Medical Systems FMI Class II 1998-08-06
K981907 V.F.I.-VISCOUS FLUID INFUSION TUBING SET Peregrine Surgical , Ltd. MRH Class II 1998-08-04
K982284 POWDERED GREEN LATEX EXAMINATION GLOVES Besglove Medicare Sdn. Bhd. LYY Class I 1998-08-03
K982257 VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED Taian Plastics Products (Jingxing) Co., Ltd. LYZ Class I 1998-08-03
K981776 ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X Alexander Mfg. Co. FRN Class II 1998-08-03
K982285 POWDERFREE GREEN LATEX EXAMINATION GLOVES Besglove Medicare Sdn. Bhd. LYY Class I 1998-08-03

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