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General Hospital

15,616 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories (K173259)Case Medical, Inc.2018-06-13
Vinyl Examination Glove (Clear, Non-Colored) (K180861)Zhicheng Trading Co., Ltd.2018-06-13
Powder Free Vinyl Patient Examination Gloves (Yellow, White) (K180260)Shanxi Hongjin Plastic Technology Co., Ltd.2018-06-12
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim (K180452)Riverstone Resources Sdn Bhd2018-06-12
Perfusor® Space Syringe Infusion Pump System (K172831)B.Braun Medical, Inc.2018-06-12
Vinyl Examination Glove (Clear, Non-Colored) (K180849)Huifu Trading Co., Ltd.2018-06-11
Omnican fine (K173803)B.Braun Medical, Inc.2018-06-11
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color (K171422)Ever Global (Vietnam) Enterprise Corp2018-06-11
Digital Thermometer (K172121)Fudakang Industrial Co., Ltd.2018-06-07
Guarded Luer Connector (K173577)International Medical Industries, Inc.2018-06-07
Sterilization Pouch/Roll Made with Tyvek (K180672)Sigma Medical Supplies Corporation2018-06-06
POWDER FREE LATEX EXAMINATION GLOVE (K173053)Professional Latex Sdn Bhd2018-06-06
SIGMA Sterilization Pouch and Roll (K180661)Sigma Medical Supplies Corp.2018-06-05
Omnipod DASH Insulin Management System (K180045)Insulet Corporation2018-06-01
NEOSHIELD (K172499)JMS North America Corporation2018-06-01
MN-111 (K172825)W&H Sterilization S.R.L.2018-05-30
VERIFY Spore Test Strip for S40 Sterilant (K180553)STERIS Corporation2018-05-29
DripAssist Plus (K172242)Shift Labs, Inc.2018-05-25
Infrared Thermometer (K172889)Shenzhen Pacom Medical Instruments Co., Ltd.2018-05-25
VACUETTE SAFELINK Holder with male luer lock (K180545)Greiner Bio-One Na, Inc.2018-05-21
Biowy PlCC Catheter (K173956)Biowy Corporation2018-05-21
Sterile Hypodermic Needle for Single Use (K180259)Jiangsu Shenli Medical Production Co., Ltd.2018-05-18
CADD Yellow High Volume Administration Set with NRFit connector (K172592)Smiths Medical Asd, Inc.2018-05-17
Infrared Thermometer (K172894)Shenzhen Jiacom Technology CO ., Ltd.2018-05-17
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K180476)Comfort Rubber Gloves Industries Sdn. Bhd.2018-05-15
RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder (K173279)Myco Medical Supplies, Inc.2018-05-14
HealthBeacon HB2 Sharps Bin (K172719)Healthbeacon, Ltd.2018-05-11
Infrared Body Thermometer (K180385)Hetaida Technology Co., Ltd.2018-05-11
Spectrum IQ Infusion System, Dose IQ Safety Software (K173084)Baxter Healthcare Corporation2018-05-11
OsteoMed QuickFix Hybrid MMF Sterilization Tray (K173391)Osteomed, LLC2018-05-10
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange (K172867)Gmp Medicare Sdn Bhd (F25)2018-05-10
Graftgun Universal Graft Delivery System (K180937)SurGenTec, LLC2018-05-10
STERIZONE VP4 Sterilizer (K172191)Tso3, Inc.2018-05-09
MEDRAD® Imaging Bulk Package Transfer Set (K173913)Bayer U.S., LLC2018-05-04
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172864)Maxter Glove Manufacturing Sdn Bhd2018-05-02
BiliLux (K172656)Draeger Medical Systems, Inc.2018-05-01
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) (K180696)Medline Industries, Inc.2018-04-30
QiF Blood and Fluid Warmer (K180154)Quality IN Flow , Ltd.2018-04-27
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue (K172923)Top Glove Sdn. Bhd.2018-04-26
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology (K180548)C.R. Bard, Inc (Bard Has Joined Bd)2018-04-26
3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader (K173519)3M Company2018-04-23
Hickman TriFusion Catheter (K172511)C.R. Bard, Inc.2018-04-20
Isolette 8000 plus (K172154)Draeger Medical Sytems, Inc.2018-04-19
VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set (K173757)Greiner Bio-One Na, Inc.2018-04-19
AViTA Radar Thermo NT16 Series IR Thermometer (K172427)Avita Corporation2018-04-19
Stryker Universal Select Sterilization Tray System (K173615)Paragon Medical2018-04-18
FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device (K180588)Teleflex Medical2018-04-17
mCare Powder-free Blue Nitrile Examination Gloves (K172930)Mercator Medical (Thailand), Ltd.2018-04-13
C3 Wave System (K180567)Medical Components, Inc. (dba MedComp)2018-04-12
Neodent Instrument Kits (K171713)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2018-04-05
SYSTEM 1E Liquid Chemical Sterilant Processing System (K180342)Steris Corporations2018-04-04
Instrument basket, for EndoEYE (K171692)Olympus Winter & Ibe GmbH2018-04-02
Nipro Syringe (K173029)Nipro Medical Corporation2018-03-30
SUPERCATH 5 (26G) (K172496)Togo Medikit Co., Ltd.2018-03-23
DROPLET PEN NEEDLE (K171982)Htl-Strefa S.A2018-03-21
ATS Thermal Imaging Probe, ATS Patient Interface Unit (K180148)Securus Medical Group, Inc.2018-03-21
3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H (K173437)3M Company2018-03-19
Dynarex Three-Way Stopcock (K172266)Dynarex Corporation2018-03-14
Infrared Thermometer (K172795)Shenzhen Jumper Medical Equipment Co., Ltd.2018-03-14
STERIZONE VP4 Sterilizer (K173694)Tso3, Inc.2018-03-13
Powder-free Clear Vinyl Patient Examination Gloves (K173078)Yongsheng Medical Products Co., Ltd.2018-03-09
Amsco Evolution Medium Steam Sterilizer (K173481)STERIS Corporation2018-03-09
primeMidline Catheters (K173114)Pfm Medical, Inc.2018-03-07
MiniMed Mio Advance infusion set (K173879)Unomedical A/S2018-03-05
Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K173942)Central Medicare Sdn Bhd2018-03-05
AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray (K172062)Medscience Science Research Group, Inc.2018-03-05
System 1 endo Liquid Chemical Sterilant Processing System (K173256)STERIS Corporation2018-03-02
Infrared Thermometer (K171214)Shenzhen Brav Electronic Technologies Co., Ltd.2018-03-02
VERIFY Chemical Indicator for S40 Sterilant (K173428)STERIS Corporation2018-03-02
Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers (K170304)Astell Scientific Limited2018-03-02
CELERITY 20 HP Challenge Pack (K173488)STERIS Corporation2018-03-01
VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag (K173633)STERIS Corporation2018-02-28
Vygon PICCs (K172899)Vygon USA2018-02-26
Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 (K173493)STERIS Corporation2018-02-23
Amsco Evolution Medium Steam Sterilizer (K173485)STERIS Corporation2018-02-22
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) (K173490)STERIS Corporation2018-02-22
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) (K171171)Koon Seng Sdn Bhd2018-02-22
U&U Indicator tape and strip (K171823)U&U Medical Technology Co, Ltd.2018-02-22
Silicone Peripherally Inserted Central Venous Catheter Set/Tray (K171994)Cook Incorporated2018-02-22
CELERITY 20 Steam Process Challenge Device for Gravity Cycles (K173629)STERIS Corporation2018-02-21
Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles (K173626)STERIS Corporation2018-02-21
HydroPICC (K172885)Access Vascular, Inc.2018-02-20
U-MED Powder Free Polyethylene Examination Gloves,Blue Color (K173228)Jiangsu U-Med Rubber & Plastic Products Co., Ltd.2018-02-20
Vinyl Patient Examination Glove (Yellow) (K173580)Nature Medical Products Co., Ltd.2018-02-15
Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J (K172870)Hangzhou Hua'An Medical&Health Instruments Co.,Ltd2018-02-13
Vinyl Patient Examination Glove (Yellow) (K173561)Yurun Glove Co., Ltd.2018-02-12
CELERITY 20 Steam Biological Indicator (K173634)STERIS Corporation2018-02-12
CELERITY 20 Steam Incubator (K173670)STERIS Corporation2018-02-12
PRO-LITE Sterilization Trays (K172755)STERIS Corporation2018-02-09
CELERITY 20 HP Biological Indicator (K172752)STERIS Corporation2018-02-09
3M Attest Rapid Readout Biological Indicator (K173435)3M Company2018-02-09
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K172749)STERIS Corporation2018-02-09
VERIFY VH2O2 Indicator Tape (K172753)STERIS Corporation2018-02-09
VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label (K172746)STERIS Corporation2018-02-09
AT-6XX Series Infrared Thermometer (K171455)Xiamen Acurio Instruments Co., Ltd.2018-02-09
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack (K172748)Steris Corporations2018-02-09
V-PRO maX 2 Low Temperature Sterilization System (K172754)STERIS Corporation2018-02-09
SteriZign Signatur Device Protection System (K171520)Sterizign Precision Technologies, LLC2018-02-07
Sporview VH202 BI (K171287)Spsmedical Supply Corp. A Division of Cantel Medical2018-02-01
Merit Syringe (K173601)Merit Medical Systems, Inc.2018-01-31
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