meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
31
Latest Decision
2009-09-25

Clearances · page 42 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K092415 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Elegance Plastic Product LYZ Class I 2009-09-25
K090339 BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2 Belimed Sauter AG FLE Class II 2009-09-23
K091942 POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES Zibo Intco Medical Products Co., Ltd. LYZ Class I 2009-09-21
K092327 MICRO-TOUCH NITRA FREE Ansell Healthcare Products, LLC LZA Class I 2009-09-21
K092100 POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES Tangshan Hongxing Plastic Products Co., Ltd. LYZ Class I 2009-09-18
K092000 POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES Shangdong Zibo Shanchuan Medical Instruments Co. LYZ Class I 2009-09-18
K091731 AMSCO EVOLUTION MEDIUM STEAM STERILIZER STERIS Corporation FLE Class II 2009-09-17
K091953 PRO-PICC Medcomp LJS Class II 2009-09-16
K092200 POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) Gx Corporation Sdn Bhd LZA Class I 2009-09-16
K092347 PRO-PICC CT Medcomp LJS Class II 2009-09-16
K092416 POWDERED VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Elegance Plastic Product LYZ Class I 2009-09-16
K091488 FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C Footprint Medical LJS Class II 2009-09-14
K092413 INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES Inviro Medical Devices, Inc. MEG Class II 2009-09-04
K092430 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES Inviro Medical Devices, Inc. MEG Class II 2009-09-04
K091652 NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS Hartalega Sdn Bhd LZA Class I 2009-09-04
K091685 KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 Kimberly-Clark Corp. FRG Class II 2009-09-03
K091676 MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 Omron Healthcare, Inc. FLL Class II 2009-09-01
K083665 VERIFY SCBI 275F 3-10 STERIS Corporation FRC Class II 2009-09-01
K090156 ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 Wcm Waste & Compliance Management, Inc. FMI Class II 2009-09-01
K091200 XTRACT SYRINGE KEYS Xtract Solutions, LLC FMF Class II 2009-08-21
K090783 TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE Tuttnauer U.S.A Co, Ltd. FLE Class II 2009-08-20
K090818 KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS KARL STORZ Endoscopy-America, Inc. KCT Class II 2009-08-18
K092022 TISSU TRANS HARVEST TUBING Shippert Medical Technologies Corp. KYZ Class I 2009-08-17
K083571 ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR Purna Bina Sdn Bhd LYY Class I 2009-08-13
K090551 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Tangshan Zhongpu Plastic Products Co., Ltd. LYZ Class I 2009-08-12
K091279 NIPRO DISPOSABLE SYRINGE Nipro Medical Corporation FMF Class II 2009-08-12
K090199 JIAJIAN ACUPUNCTURE NEEDLE Wuxi Jiajian Medical Instrument Co., Ltd. MQX Class II 2009-08-11
K091521 POWERED VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Century Plastic Co., Ltd. LYZ Class I 2009-08-10
K083643 VERIFY 275F GRAVITY INDICATORS STERIS Corporation JOJ Class II 2009-08-07
K083429 I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT Weihai Jierui Medical Products Co., Ltd. FOZ Class II 2009-08-07
K083087 ECOCEL Polichem S.A KMF Class I 2009-08-07
K091324 SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET C.R. Bard, Inc. LJS Class II 2009-08-07
K091167 SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES Shina Corp. FMF Class II 2009-08-06
K083097 AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation MLR Class II 2009-08-03
K083408 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Wrp Asia Pacific Sdn. Bhd. LZC Class I 2009-07-31
K083410 POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM Wrp Asia Pacific Sdn. Bhd. LZC Class I 2009-07-31
K083913 CHESSON LABS LIQUID BANDAGE Chesson Laboratory Associates, Inc. KMF Class I 2009-07-31
K091422 NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) Novapro Co., Ltd. LYZ Class I 2009-07-30
K091662 POWDERED VINYL PATIENT EXAMINATION GLOVES Zhangjiagang Fengyuan Plastic Products Co., Ltd. LYZ Class I 2009-07-30
K083409 POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL Wrp Asia Pacific Sdn. Bhd. LZC Class I 2009-07-29
K090828 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES Ultrawin Sdn Bhd LZA Class I 2009-07-28
K091690 SHARP CHUTE Heathrow Scientific, LLC MMK Class II 2009-07-28
K091661 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zhang Jia Gang Huayuan Plastic Co. , Ltd. LYZ Class I 2009-07-27
K091147 POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) Smart Glove Corp. Sdn Bhd LZA Class I 2009-07-27
K091663 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zhangjiagang Fengyuan Plastic Products Co., Ltd. LYZ Class I 2009-07-27
K091141 THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS Knit-Rite, Inc. DWL Class II 2009-07-24
K091421 NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED) Novapro Co., Ltd. LYZ Class I 2009-07-23
K091586 VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN Medcomp LJS Class II 2009-07-23
K090245 SOLO INSULIN PATCH PUMP Medingo , Ltd. LZG Class II 2009-07-23
K082647 POWDERED VINYL PATIENT EXAMINATION GLOVES Tangshan Dar Plastic & Rubber Products Co. , Ltd. LYZ Class I 2009-07-22
K083761 ALATECH POWDER FREE LATEX EXAMINATION GLOVE Alatech Healthcare, LLC LYY Class I 2009-07-22
K091383 VINYL POWDER FREE EXAMINATION GLOVE Shun Tong Co., Ltd. LYZ Class I 2009-07-22
K091429 VINYL POWDER FREE EXAMINATION GLOVE Shun DA (Xinghua) Co., Ltd. LYZ Class I 2009-07-22
K091384 VINYL POWDERED EXAMINATION GLOVE Shun Tong Co., Ltd. LYZ Class I 2009-07-20
K083419 ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 Actherm, Inc. FLL Class II 2009-07-16
K091474 EASY.TOUCH INSULIN SYRINGE Masters Healthcare, LLC FMF Class II 2009-07-09
K091308 ALARIS PC UNIT, MODELS 8000 AND 8015 Cardinal Health 303,Inc. FRN Class II 2009-07-09
K091523 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Century Plastic Co., Ltd. LYZ Class I 2009-07-09
K082620 ONCE-A-DAY VERTOS TEST PACK Propper Mfg. Co., Inc. JOJ Class II 2009-07-08
K091431 POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES Zibo Yusheng Plastic Products Co., Ltd. LYZ Class I 2009-07-08
K090194 POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR Shen Wei (Usa), Inc. LZA Class I 2009-07-07
K090670 MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER Midmark Corp. FLE Class II 2009-07-07
K083686 BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES Anhui Kangda Medical Products Co., Ltd. FMF Class II 2009-07-02
K091377 BD FLU+ SYRINGE Becton, Dickinson & CO FMF Class II 2009-07-02
K091627 SMITH & NEPHEW INSTRUMENT TRAYS Smith & Nephew, Inc. KCT Class II 2009-07-02
K091670 BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER Becton, Dickinson & CO LJS Class II 2009-07-01
K091855 THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 Belmont Instrument Corp. FRN Class II 2009-07-01
K083689 INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM B.Braun Medical, Inc. FRN Class II 2009-07-01
K090336 SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS Sunmax Enterprise Shanghai Co. , Ltd. LZA Class I 2009-07-01
K090910 HANSO ACUPUNCTURE NEEDLE Hansol Medical Co. MQX Class II 2009-06-30
K083583 XPRESSE INJECTION SYSTEM Nordson Efd FMF Class II 2009-06-30
K090560 CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS Conmed Linvatec KCT Class II 2009-06-29
K091136 AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 STERIS Corporation FLE Class II 2009-06-29
K090564 TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 Truly Instrument Limited FLL Class II 2009-06-24
K091427 VINYL POWDERED EXAMINATION GLOVE Shun DA (Xinghua) Co., Ltd. LYZ Class I 2009-06-23
K083305 POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM Wrp Asia Pacific Sdn. Bhd. LZC Class I 2009-06-18
K091466 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 Medcomp LJS Class II 2009-06-17
K090848 PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM Premier Brands of America, Inc. FQH Class II 2009-06-17
K082110 DUAL SYRINGE HOLDER Surgin Surgical Instrumentation, Inc. FMG Class II 2009-06-17
K082367 INFANT SLEEP BEANIE Life Innovations, LLC FRP Class I 2009-06-12
K091181 LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS Smiths Medical MD, Inc. MRZ Class II 2009-06-12
K090929 STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE Shanghai Double Dove Industrial Co., Ltd. FMF Class II 2009-06-12
K090426 VAKU-8 BLOOD COLLECTION NEEDLES Myco Medical Supplies, Inc. FMI Class II 2009-06-12
K083687 BAIXIN INTRAVASCULAR ADMINISTRATION SET Anhui Kangda Medical Products Co., Ltd. FPA Class II 2009-06-11
K090012 DISPOSABLE INFUSION SET Shan Dong Wei Gao Group Medical Polymer Products FPA Class II 2009-06-11
K091589 MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1 Microlife Intellectual Property GmbH FLL Class II 2009-06-10
K090680 HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE Becton, Dickinson & CO NZW Class II 2009-06-10
K091315 COVIDIEN EXTENDED TIP APPLICATOR Confluent Surgical,Inc FMF Class II 2009-06-05
K083723 A6 LUER ACCESS DEVICE B.Braun Medical, Inc. FPA Class II 2009-06-05
K090284 RES-Q INFANT WEDGE AND SLING Cr Enterprises, LLC FRP Class I 2009-06-05
K090412 POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). Gx Corporation Sdn Bhd LZA Class I 2009-06-01
K091151 POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN Gx Corporation Sdn Bhd LZA Class I 2009-06-01
K082957 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS Siam Sempermed Corp., Ltd. LZA Class I 2009-05-29
K082858 EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER Alcavis International, Inc. FQH Class II 2009-05-27
K091099 C-PORT - HP POWER INJECTABLE PORT Phs Medical GmbH LJT Class II 2009-05-22
K083514 TERUMO SYRINGE WITH/WITHOUT NEEDLE Terumo Europe N.V. FMF Class II 2009-05-22
K090457 ORALUBE Pulpdent Corporation ONK Class I 2009-05-21
K082817 PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M Primus Sterilizer Company, LLC FLE Class II 2009-05-21
K090736 POWER INFUSER, MODEL M100B-3A ZOLL Medical Corporation FRN Class II 2009-05-20
K090520 STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE) Shandong Huayue Glove Co., Ltd. LYZ Class I 2009-05-18

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