meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
32
Latest Decision
2018-02-22

Clearances · page 22 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K173490 Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) STERIS Corporation FLE Class II 2018-02-22
K173485 Amsco Evolution Medium Steam Sterilizer STERIS Corporation FLE Class II 2018-02-22
K173626 Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles STERIS Corporation FRC Class II 2018-02-21
K173629 CELERITY 20 Steam Process Challenge Device for Gravity Cycles STERIS Corporation FRC Class II 2018-02-21
K173228 U-MED Powder Free Polyethylene Examination Gloves,Blue Color Jiangsu U-Med Rubber & Plastic Products Co., Ltd. LZA Class I 2018-02-20
K172885 HydroPICC Access Vascular, Inc. LJS Class II 2018-02-20
K173580 Vinyl Patient Examination Glove (Yellow) Nature Medical Products Co., Ltd. LYZ Class I 2018-02-15
K172870 Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J Hangzhou Hua'An Medical&Health Instruments Co.,Ltd FLL Class II 2018-02-13
K173634 CELERITY 20 Steam Biological Indicator STERIS Corporation FRC Class II 2018-02-12
K173561 Vinyl Patient Examination Glove (Yellow) Yurun Glove Co., Ltd. LYZ Class I 2018-02-12
K173670 CELERITY 20 Steam Incubator STERIS Corporation FRC Class II 2018-02-12
K171455 AT-6XX Series Infrared Thermometer Xiamen Acurio Instruments Co., Ltd. FLL Class II 2018-02-09
K172753 VERIFY VH2O2 Indicator Tape STERIS Corporation JOJ Class II 2018-02-09
K172755 PRO-LITE Sterilization Trays STERIS Corporation KCT Class II 2018-02-09
K172746 VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label STERIS Corporation JOJ Class II 2018-02-09
K172754 V-PRO maX 2 Low Temperature Sterilization System STERIS Corporation MLR Class II 2018-02-09
K172752 CELERITY 20 HP Biological Indicator STERIS Corporation FRC Class II 2018-02-09
K172748 VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack Steris Corporations FRC Class II 2018-02-09
K172749 Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS Corporation FRG Class II 2018-02-09
K173435 3M Attest Rapid Readout Biological Indicator 3M Company FRC Class II 2018-02-09
K171520 SteriZign Signatur Device Protection System Sterizign Precision Technologies, LLC KCT Class II 2018-02-07
K171287 Sporview VH202 BI Spsmedical Supply Corp. A Division of Cantel Medical FRC Class II 2018-02-01
K173601 Merit Syringe Merit Medical Systems, Inc. FMF Class II 2018-01-31
K172159 Getinge GSS67N Series Steam Sterilizer Maquet GmbH FLE Class II 2018-01-30
K171367 SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) Sanrea Healthcare Products Pvt, Ltd. LYY Class I 2018-01-26
K171954 ClearLine IV Clearline MD OKL Class II 2018-01-25
K173584 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader 3M Company FRC Class II 2018-01-22
K163600 Kit Boxes and Kit Plates Nobel Biocare AB KCT Class II 2018-01-22
K172319 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System STERIS Corporation MLR Class II 2018-01-18
K172962 Nurture Rest Neonatal Loving Kare, Inc. OUW Class I 2018-01-18
K173730 Kinsa QuickCare Thermometer Kinsa, Inc. FLL Class II 2018-01-17
K173113 Medline Disposable Electronic Thermometer Probe Cover Medline Industries, Inc. FLL Class II 2018-01-17
K173479 NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) Novo Nordisk, Inc. FMI Class II 2018-01-17
K171148 Aleo BME Liquid Bandage Aleo Bme, Inc. KMF Class I 2018-01-12
K171737 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves Ansell Healthcare Products, LLC LZA Class I 2017-12-29
K172474 Celerity 20 HP Biological Indicator STERIS Corporation FRC Class II 2017-12-29
K172357 Disposable Powder Free Vinyl Exam Glove, Clear/Yellow Ever Growth (Vietnam) Co. , Ltd. LYZ Class I 2017-12-29
K171530 Deltaven XiV Max, Deltaven XiV Max FF Delta Med Spa FOZ Class II 2017-12-21
K171109 Praxiject 0.9% NaCl Medxl, Inc. NGT Class II 2017-12-21
K173332 OMNI Surgical System Sight Sciences, Inc. MRH Class II 2017-12-21
K172861 Digital thermometer(with disposable thermometer cover) Hangzhou Hua'An Medical&Health Instruments Co.,Ltd FLL Class II 2017-12-19
K171483 ArchFlo CT Midline Medcomp (Dba Medical Components, Inc.) PND Class II 2017-12-15
K173354 BD Nexiva Diffusics Closed IV Catheter Systems Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 2017-12-15
K173017 Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Anhui Kindguard Medical Supplies Technology Co., Ltd. LYZ Class I 2017-12-15
K170881 ISP Safety Huber Needle Infusion Set Infusion Safety Products, Inc. PTI Class II 2017-12-14
K173137 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) Hartalega Sdn Bhd LZA Class I 2017-12-12
K172432 SporView Rapid Read Biological Indicator Crosstex/Spsmedical, A Division of Cantel Medical FRC Class II 2017-12-12
K170988 DropSafe Safety Pen Needle Htl-Strefa S.A FMI Class II 2017-12-12
K170276 Safety Blood Collection Device for Single Use Gemtier Medical (Shanghai), Inc. FMI Class II 2017-12-11
K170934 C3 Wave System Medical Components, Inc (Dba Medcomp_ LJS Class II 2017-12-06
K173385 Graft Delivery, DePuy Synthes Micromedics, Inc. (D/B/A Nordson Medical) FMF Class II 2017-11-30
K171578 Infrared thermometer Shenzhen Aeon Technology Co., Ltd. FLL Class II 2017-11-30
K172642 Orange Non Sterile Powder Free Nitrile Examination Gloves Central Medicare Sdn Bhd LZC Class I 2017-11-28
K172292 SALUS - Hygiene Instrument Reprocessing Container Scican , Ltd. KCT Class II 2017-11-24
K172678 THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE Shen Wei USA, Inc. LZA Class I 2017-11-24
K170662 Non Contact Infrared Forehead Thermometer Intrinity Global Limited FLL Class II 2017-11-22
K171743 Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves Smart Glove Corporation Sdn. Bhd. LZA Class I 2017-11-17
K172850 SterilContainer with PrimeLine Pro Lid Aesculap, Inc. KCT Class II 2017-11-17
K172472 Micro-MEC 1.8% Glutaraldehyde Monitor Strip STERIS Corporation JOJ Class II 2017-11-17
K171873 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs Zhonghong Pulin Medical Products Co., Ltd. LZA Class I 2017-11-15
K173016 Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color Anhui Kindguard Medical Supplies Technology Co., Ltd. LYZ Class I 2017-11-15
K172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Central Medicare Sdn Bhd LZC Class I 2017-11-13
K170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories Intervene Group, Ltd. FMF Class II 2017-11-09
K171131 MHC Standard and NRFit Tip Syringes Mazza Healthcare, LLC FMF Class II 2017-11-08
K170595 IV Administration Sets B.Braun Medical, Inc. FPA Class II 2017-11-07
K172442 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) Hartalega NGC Sdn. Bhd. LZA Class I 2017-11-06
K170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site B.Braun Medical, Inc. PTI Class II 2017-11-03
K163646 Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator Terragene S.A. FRC Class II 2017-11-02
K163223 ORCA (tm) - Operational Rescue Containment Apparatus Isovac Products, LLC LGM Class II 2017-11-02
K170437 Sterisheet Sterilization Wrap Andersen Sterilizers, Inc. FRG Class II 2017-11-01
K162812 Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set Unomedical A/S FPA Class II 2017-11-01
K170439 AN87 Dosimeter Andersen Sterilizers, Inc. JOJ Class II 2017-11-01
K170513 MAUSER PG II Sharps Container Mauzer USA, LLC MMK Class II 2017-11-01
K170432 Anprolene AN75 Ethylene Oxide Gas Sterilizer Andersen Sterilizers, Inc. FLF Class II 2017-10-31
K170427 Anprolene SteriTest Andersen Sterilizers, Inc. FRC Class II 2017-10-31
K170426 AN85/AN86 EO Indicators Andersen Sterilizers, Inc. JOJ Class II 2017-10-30
K170429 Tyvek Sterilization Pouches with Chevron Seal Andersen Sterilizers, Inc. FRG Class II 2017-10-27
K170585 Skylife Neolight, LLC LBI Class II 2017-10-27
K171931 Celerity ECG Cable Accessory Pack Medcomp (Medical Components, Inc.) LJS Class II 2017-10-26
K170226 iTotal Family Reusable Instrument Tray Conformis, Inc. KCT Class II 2017-10-25
K170423 DentureID Microchip Cmp Industries, LLC PYQ Class II 2017-10-25
K170612 STERILE VINYL EXAMINATION GLOVES, Powder Free Primus Gloves Pvt Limited LYZ Class I 2017-10-23
K162216 GRI-FILL PERISTALTIC SET Laboratorios Grifols, S.A. LHI Class II 2017-10-19
K162042 OptiScanner 5000 Glucose Monitoring System Optiscan Biomedical Corp. LZF Class II 2017-10-16
K162362 PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator Pms Tibbi Cihazlar Teknolojisi San VE Tic AS FRG Class II 2017-10-13
K171782 Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs Blue Sail Medical Co.,Ltd LZA Class I 2017-10-12
K171796 Vial Adapter 15mm Medimop Medical Project , Ltd. LHI Class II 2017-10-12
K171874 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) Hartalega Sdn Bhd LZA Class I 2017-10-12
K171984 Clickfine Pen Needle, Penfine Classic Pen Needle Ypsomed AG FMI Class II 2017-10-11
K163526 Bilicocoon™ Phototherapy System Neomedlight LBI Class II 2017-10-06
K171182 ri-former Predictive Thermometer Rudolf Riester GmbH FLL Class II 2017-10-04
K172884 Arisure Closed Vial Adapter Yukon Medical LHI Class II 2017-10-03
K172397 Sherlock 3CG Tip Positioning System Stylet C.R. Bard, Inc. LJS Class II 2017-09-29
K172631 Arisure Dry Spike Yukon Medical LHI Class II 2017-09-29
K170262 Digital Thermometer K-Jump Health Co., Ltd. FLL Class II 2017-09-28
K171215 QiF Blood and Fluid Warmer Quality IN Flow , Ltd. LGZ Class II 2017-09-27
K172015 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) Careglove Global Sdn. Bhd. LZA Class I 2017-09-26
K171460 Powder-free Clear Vinyl Patient Examination Gloves Shandong Zhiwei Medical Products, Co. , Ltd. LYZ Class I 2017-09-24
K172544 IV Fat Emulsion Administration Sets Baxter Healthcare Corporation FPA Class II 2017-09-22
K170956 SYSTEM 1E Liquid Chemical Sterilant Processing System STERIS Corporation MED Class II 2017-09-22

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