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General Hospital

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

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RecordFirmDate
PICC Tip Positioning Aid (K152261)Nostix, LLC2015-10-21
Temple Touch Pro (TTP) Non-invasive temperature monitoring system (K150160)Medisim, Ltd.2015-10-20
MTS300 Multiple Tray Sterilization System (K152014)Pmbs, LLC2015-10-20
Terumo SurGuard 3 Safety Hypodermic Needle (K152362)Terumo (Philippines) Corporation2015-10-16
MIS Spine Frame Instrument Case (K151347)Thompson Surgical Instruments2015-10-16
Mini Needle (K151571)Ocujet, LLC2015-10-14
DripAssist (K150687)Shift Labs2015-10-13
SterilContainer S (K151242)Aesculap, Inc.2015-10-09
Powder Free Nitrile (Black) Examination Gloves (K151528)Gallant Quality Sdn. Bhd.2015-10-09
3M Comply Hydrogen Peroxide Indicator Tape 1228 (K150694)3M Company2015-10-01
Q2 Intravenous Adminstration Sets and Extension Sets (K151079)Quest Medical, Inc.2015-09-30
3M Comply Hydrogen Peroxide Chemical Indicator 1248 (K150622)3M Company2015-09-29
Intradermal Adapter (K151777)West Pharmaceutical Services, Inc.2015-09-29
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC (K152409)Navilyst Medical, Inc.2015-09-24
U & U Intravascular Administration Set (K151151)U&U Medical Technology Co, Ltd.2015-09-24
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) (K151684)Hartalega NGC Sdn. Bhd.2015-09-18
Powder Free Nitrile Examination Glove (K151208)Vrg Khai Hoan Joint Stock Company2015-09-14
KleenGel Dispenser (K143177)Kleengel, LLC2015-09-14
U&U Sterilization Pouch and Roll (K143637)U&U Medical Technology Co, Ltd.2015-09-09
PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON (K151249)Pureway Compliance, Inc.2015-09-04
TempTraq TT-100 (K143267)Blue Spark Technologies, Inc.2015-09-02
The Belmont Hyperthermia Pump (K152208)Belmont Instrument Corporation2015-09-02
BD Single Use, Hypodermic Syringe (K151766)Becton, Dickinson and Company2015-09-02
Normal Saline Flush (K150143)Nurse Assist, Inc.2015-08-31
NuVasive Sterilization Trays (K143579)Nu Vasive, Incorporated2015-08-28
Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles (K142760)K.S. Choi Corporation2015-08-25
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) (K151343)Hartalega NGC Sdn. Bhd.2015-08-24
Turbo High-Flow Non-coring Needle (K151341)Norfolk Medical2015-08-20
Instru-Safe Instrument Protection System (K151166)Summit Medical, Inc.2015-08-18
SterilContainer S (K143729)Aesculap, Inc.2015-08-18
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR (K143289)Yty Industry (Manjung) Sdn Bhd2015-08-18
Accu-Chek FlexLink Plus infusion set (K143446)Roche Diagnostics GmbH2015-08-13
TM SAFETY NEEDLE (K142765)Thinkmed Medical Technology Co., Ltd.2015-08-11
Cathivex ¿GV filter units (K143583)Merck Millipore , Ltd.2015-08-11
SmartSite Vented Vial Access Device (K151963)Yukon Medical, LLC2015-07-31
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (K150874)Novo Nordisk, Inc.2015-07-31
Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile), (K143277)Lifestyle Safety Products (Hui Zhou) Co., Ltd.2015-07-29
BD Angiocath IV Catheter, BD Insyte IV Catheter (K151698)Becton Dickinson Infusion Therapy Systems, Inc.2015-07-27
IV Administration Sets with 200(micro)m Blood Filter (K143082)B.Braun Medical, Inc.2015-07-24
Powder-Free Yellow Vinyl Patient Examination Gloves (K143347)Zibo Zhouheng Plastic Products Co., Ltd.2015-07-24
Halo (K150486)J & J Solutions, Inc. D/B/A/ Corvida Medical2015-07-24
Powder-Free White Vinyl Patient Examination Gloves (K143346)Zibo Changda Plastic Products Company, Limited2015-07-22
MedSource ClearSafe Safety IV Catheter (K150611)Medsource International2015-07-15
The VersaJet II Hydrosurgery System (K143115)Smith & Nephew, Inc.2015-07-15
EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural (K150903)Maanshan Bond Medical Instruments Co., Ltd.2015-07-15
Penguin In-Line Warmer (K150484)Creche Innovations2015-07-09
Powder Free Vinyl Patient Examination Gloves, Yellow Color (K143340)Zibo Ling Yun Medical Products Co, Ltd.2015-07-09
Arrow Endurance Extended Dwell Peripheral Catheter System (K151513)Arrow Internation, Inc. (Subsidiary of Teleflex Inc.)2015-07-08
SterilContainer S System (K142970)Aesculap, Inc.2015-07-08
Disposable Safety Self-destructive Syringes, 5 ML (K143070)Jiangsu Yile Medical Article Co., Ltd.2015-07-07
Graft Delivery Device with Integrated Stylet (K151543)Micromedics, Inc. (D/B/A Nordson Medical)2015-07-07
3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization (K150477)3M Company2015-07-02
Proteus Digital Health Feedback Device (K150494)Proteus Digital Health, Inc.2015-06-27
Droplet Pen Needles (K143437)Htl-Strefa S.A2015-06-25
K-Pack II Needle - 29G x 5/16 Thin Wall (K151398)Terumo Europe N.V.2015-06-25
Instru-Safe Instrument Protection System (K150540)Summit Medical, Inc.2015-06-22
POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) (K150340)Hebei Hongsen Plastics Technology Co, Ltd.2015-06-18
Fusion Black Powder-Free Nitrile Exam Glove (K150113)Halyard Health2015-06-18
I.V. Catheter (K142797)Jiangxi Sanxin Medtec Co., Ltd.2015-06-18
Infusomat Space Volumetric Infusion Pump (K142596)B.Braun Medical, Inc.2015-06-18
BELIMED STEAM STERILIZER MST-H (K141879)Sauter AG2015-06-17
Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL (K150414)Industrial Clothings (Pvt), Ltd.2015-06-12
Luma Wrap (K142416)Salter Labs2015-06-12
KM Needles (Acupuncture Needle) (K142920)K.M.S., Inc.2015-06-10
SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) (K143520)Crosstex2015-06-09
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K150593)Hartalega Sdn Bhd2015-06-09
Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) (K150662)Ypsomed AG2015-06-09
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K143715)Better Plastic Co., Ltd.2015-06-05
HumaPen Luxura (K142518)Eli Lilly and Company2015-06-05
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology (K150109)Arrow International (A Subsidiary of Teleflex, Inc.)2015-06-05
Safe'n'Sound Staked Passive Delivery System - Plajex version (K150562)Nemera2015-06-02
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets (K143263)Covidien2015-05-29
Instru-Safe Instrument Protection System (K142768)Summit Medical, Inc.2015-05-29
Imed Technology Intravascular Administration Set, Imed Technology Extension Set (K150513)Imed Technology, Inc.2015-05-28
DualCap (K142806)Catheter Connections, Inc.2015-05-22
Vital-Port Vascular Access System Power Injectable Port (K150733)Cook Incorporated2015-05-21
U&U Bowie-Dick Test Pack (K143629)U&U Medical Technology Co, Ltd.2015-05-19
BioFlo Midline Catheter (K150407)Navilyst Medical, Inc.2015-05-15
SCIg60 Infuser, Infuset (K142319)Emed Technologies Corporation2015-05-14
BLUE VINYL GLOVES POWDER FREE (K150224)Zibo Sanying Trade Co., Ltd.2015-05-12
MedSource Sharps Dart (K150333)Medsource International, LLC2015-05-08
Gemini Bonded Sterilization Wrap (K143147)Medline Industries, Inc.2015-05-07
Invictus Medical GelShield (K150243)Invictus Medical, Inc.2015-05-01
INVISIPORT (K141146)Stealth Therapeutics, Incorporated2015-05-01
BD FlowSmart Set (K150059)Becton, Dickinson Company2015-04-28
C3 Wave (K143238)Medcomp ( Medical Components)2015-04-24
ConMed Mixing and Delivery Kit (K142535)Conmed Corporation2015-04-23
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs (K150103)Hartalega Sdn Bhd2015-04-23
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) (K150110)Hartalega NGC Sdn. Bhd.2015-04-23
Nitroglycerin Sets with DUO-VENT Spike (K150860)Baxter Healthcare Corporation2015-04-16
InterActive Complete Surgical Tray (K142519)Implant Direct Sybron Manufacturing, LLC2015-04-15
Revital-Ox RESERT Solution Test Strip (K143333)STERIS Corporation2015-04-14
Lubricating Jelly (K142473)Sion Biotext Medical , Ltd.2015-04-13
Disposable sterile needle retractable safety syringe (K141349)Guangdong Haiou Medical Apparatus Stock Co., Ltd.2015-04-10
ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K142911)Huailai ZM Plastic Products Co., Ltd.2015-04-10
BD INTIMA II CLOSED IV CATHETER (K143610)Becton Dickinson Infusion Therapy Systems, Inc.2015-04-09
KIMGUARD ONE-STEP Sterilization Wrap (K143053)Kimberly-Clark Health Care2015-04-03
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (K142454)Advanced Sterilization Products2015-04-03
FLASHPAK STERILIZATION CONTAINER SYSTEM (K141826)Symmetry Medical Inc- Manchester2015-04-02
K-Pack II Needle-21G x 2 (K150263)Terumo Europe N.V.2015-04-01
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