FDA 510(k) Premarket Notification K003571: SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE

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Citra Labs LLC Registration: 1216032 View Registration

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ICU Medical, Inc. Registration: 1219611 View Registration

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INTL. MEDSURG CONNECTION, INC. Registration: 1423625 View Registration

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MedXL Registration: 1644312 View Registration

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DELTA HI-TECH, INC. Registration: 1721183 View Registration

MERIT MEDICAL SYSTEMS, INC. Registration: 1721504 View Registration

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ALLISON MEDICAL, INC. Registration: 1722458 View Registration

Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration

Eli Lilly and Company, Pharmaceutical Delivery Systems Registration: 1819470 View Registration

BIOMET, INC. Registration: 1825034 View Registration

ARKRAY FACTORY USA, INC. Registration: 1832816 View Registration

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ICU MEDICAL, INC. Registration: 2025816 View Registration

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Synergy Health AST, LLC Registration: 2030598 View Registration

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Isomedix Operations Inc. Registration: 2032112 View Registration

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ULTI MED, INC. Registration: 2183771 View Registration

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PHOENIX MEDICAL PRODUCTS, INC. Registration: 2320767 View Registration

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MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration

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Jung Rim Medical Industrial Co., Ltd. Registration: 3004054016 View Registration

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CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD. Registration: 3004099493 View Registration

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GLOBUS MEDICAL, INC. Registration: 3004142400 View Registration

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GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3004911384 View Registration

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Novo Nordisk (China) Pharmaceuticals, Co. Ltd. Registration: 3005186124 View Registration

SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. Registration: 3005202235 View Registration

JIANGXI SANXIN MEDTEC CO.,LTD. Registration: 3005246939 View Registration

TOP SURGICAL TAIWAN CORP. Registration: 3005301868 View Registration

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Forsure Medical Products LLC. Registration: 3005609751 View Registration

AMSINO MEDICAL (KUNSHAN) CO., LTD. Registration: 3005669815 View Registration

JIANGSU CAINA MEDICAL CO., LTD Registration: 3005670221 View Registration

MHC Medical Products Registration: 3005798905 View Registration

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Welmed, Inc. Registration: 3005841027 View Registration

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OK BIOTECH CO., LTD. Registration: 3005862821 View Registration

Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration

TOTAL VEIN SYSTEMS Registration: 3005987567 View Registration

HTL-STREFA, INC. Registration: 3006142663 View Registration

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Feel Tech Bio Co., Ltd. Registration: 3006380458 View Registration

Arrow International C.R. a.s. Registration: 3006425876 View Registration

INNOMED, S.A. DE C.V. Registration: 3006498370 View Registration

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PINE MOON ELECTRONICS CO., LTD. Registration: 3006697681 View Registration

Hangzhou Fushan Medical Appliance Co., Ltd. Registration: 3006787036 View Registration

Arteriocyte Medical Systems, Inc. Registration: 3006788678 View Registration

Ningbo Tianyi Medical Appliance CO., Ltd. Registration: 3006795797 View Registration

Delta Med SpA Registration: 3006846316 View Registration

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ShanDong WeiGao Group Medical Polymer Co., Ltd Registration: 3007084575 View Registration

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ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD. Registration: 3007590959 View Registration

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CHIRANA T.INJECTA, A.S. Registration: 3008272066 View Registration

Terumo Medical Canada, Inc. Registration: 3008307705 View Registration

Pall International, Sarl Registration: 3008412416 View Registration

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BONE SOLUTIONS, INC. Registration: 3008522639 View Registration

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ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd Registration: 3008719222 View Registration

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JMS CO.,Ltd. Chiyoda Plant Registration: 3008770691 View Registration

US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA Registration: 3008782867 View Registration

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YANGZHOU WEIDELI TRADING CO., LTD. Registration: 3008808123 View Registration

Zimmer Knee Creations, Inc. Registration: 3008812173 View Registration

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics Registration: 3008812241 View Registration

Synthes (USA) Products LLC Registration: 3008812560 View Registration

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EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration

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SHANGHAI KOHOPE MEDICAL DEVICES CO., LTD Registration: 3009077131 View Registration

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Cardinal Health Costa Rica, S.A. Registration: 3009211636 View Registration

TURNCO TOOL & INSTRUMENT, INC. Registration: 3009241418 View Registration

JMS Co.,Ltd. Miyoshi Plant Registration: 3009249481 View Registration

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JIANGSU ZHIYU MEDICAL INSTRUMENT CO., LTD Registration: 3009392898 View Registration

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Viant Medical, Inc. Registration: 3009493875 View Registration

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JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD Registration: 3009742443 View Registration

Integra Biotechnical, SA de CV Registration: 3009746061 View Registration

Gemtier Medical (Shanghai) Inc. Registration: 3009746425 View Registration

ZIEN MEDICAL TECHNOLOGIES LLC Registration: 3009756153 View Registration

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ZHEJIANG INI MEDICAL DEVICES CO., LTD Registration: 3010026090 View Registration

Apollo Renal Therapeutics, LLC Registration: 3010032115 View Registration

Teleflex LLC (NADC) Registration: 3010041511 View Registration

J & J Precision Technologies, LLC Registration: 3010120148 View Registration

BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration

Synergy Health Sterilisation UK Ltd Registration: 3010132111 View Registration

Synergy Sterilisation Rawang (m) Sdn. Bhd. Registration: 3010175289 View Registration

CAMBER SPINE TECHNOLOGIES Registration: 3010197239 View Registration

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ZHEJIANG RUNQIANG MEDICAL INSTRUMENTS CO.,LTD. Registration: 3010321647 View Registration

Arthrex, Inc. Registration: 3010331645 View Registration

Euclide Care Registration: 3010370554 View Registration

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Medifirst Co.,Ltd. Registration: 3010384323 View Registration

TRIBE MEDICAL GROUP Registration: 3010400367 View Registration

METIER MEDICAL (USA) LLC Registration: 3010405396 View Registration

SIGNA MEDICAL, INC. Registration: 3010419931 View Registration

Sterigenics Costa Rica S.R.L. Registration: 3010432890 View Registration

Ortho and Surgical Products Enterprises S.A. Registration: 3010452421 View Registration

FEELTECH CO.,LTD. Registration: 3010462274 View Registration

Regenlab USA LLC Registration: 3010512490 View Registration

PROMISEMED HANGZHOU MEDITECH CO.,LTD. Registration: 3010515547 View Registration

ATLAS MEDICAL PRODUCTS LLC Registration: 3010621964 View Registration

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BiometerPlus USA, Inc. Registration: 3010830834 View Registration

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CYDONIA PHARMA SL Registration: 3011088743 View Registration

Teleflex Medical LLC Registration: 3011137372 View Registration

Arthrex Mexico, S.A. de C.V. Registration: 3011230048 View Registration

Avanos Medical, Inc. Registration: 3011270181 View Registration

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GUANGDONG KINDLY MEDICAL DEVICE GROUP CO., LTD Registration: 3011460807 View Registration

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JB MEDICAL DEVELOPMENT, LLC DBA/MD3, LLC Registration: 3011749806 View Registration

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MEDAS, INC. Registration: 3012050423 View Registration

Synergy Health AST, LLC Registration: 3012102437 View Registration

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ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. Registration: 3012116434 View Registration

NOVEM MEDICAL S. DE R.L. DE C.V. Registration: 3012187635 View Registration

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ICU Medical, Inc. Registration: 3012307300 View Registration

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Cardinal Health K.K. Registration: 3012341425 View Registration

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Arthrex Japan G.K. (Shinjuku) Registration: 3012470322 View Registration

OCUJECT, LLC Registration: 3012478173 View Registration

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SMB CORPORATION OF INDIA Registration: 3012551896 View Registration

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PERFECT MEDICAL INDUSTRY (VN) CO., LTD Registration: 3012646696 View Registration

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CROSMED S.A. Registration: 3012883081 View Registration

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BQ PLUS MEDICAL CO.,LTD Registration: 3013023255 View Registration

Sungshim Medicare Co.,Ltd. Registration: 3013160284 View Registration

Arrow International LLC (subsidiary of Teleflex Incorporated) Registration: 3013162291 View Registration

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ENDURE INDUSTRIES, INC. Registration: 3013187142 View Registration

ORTA MEDICAL LTD Registration: 3013188547 View Registration

AIVITA BIOMEDICAL, INC. Registration: 3013221738 View Registration

VEENAK INTERNATIONAL LIMITED Registration: 3013298431 View Registration

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HERON THERAPEUTICS, INC. Registration: 3013481097 View Registration

SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD Registration: 3013496867 View Registration

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Arthrex Korea Ltd. Registration: 3013700547 View Registration

B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration

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Arthrex (Shanghai) Co., Ltd. Registration: 3014262693 View Registration

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ANHUI MEDPUREST MEDICAL TECHNOLOGY CO.,LTD Registration: 3014314985 View Registration

Duopross Meditech (Kunshan) Co., Ltd. Registration: 3014315664 View Registration

O&M Halyard, Inc. Registration: 3014421917 View Registration

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FLAT MEDICAL CO., LTD. Registration: 3014716786 View Registration

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WELLMIEN HEALTHCARE TECH.(SUZHOU) CO., LTD. Registration: 3014819517 View Registration

SHIRE HUMAN GENETIC THERAPIES, INC. Registration: 3015054258 View Registration

JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD. Registration: 3015058854 View Registration

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ZHEJIANG HUANYI STERILIZATION TECHNOLOGY CO., LTD Registration: 3015142721 View Registration

NANJING ANJIAN MEDICAL DEVICE CO.,LTD. Registration: 3015142802 View Registration

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Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration

Nypro Healthcare Baja Inc. (Albuquerque) Registration: 3015183635 View Registration

Zimmer (Shanghai) Medical International Trading Co., Ltd. Registration: 3015207155 View Registration

Merit Medical Asia Company Limited Registration: 3015225571 View Registration

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MEDIVENA SP. Z O.O. Registration: 3015485283 View Registration

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Zimmer Biomet Korea Ltd. Registration: 3015542154 View Registration

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Registration: 3015550451 View Registration

SOL-KL (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED Registration: 3015620563 View Registration

Hindustan Syringes & Medical Devices Ltd. Registration: 3015724078 View Registration

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Arrow International, LLC (subsidiary of Teleflex Incorporated) Registration: 3015859709 View Registration

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Gilero, Inc Registration: 3016733629 View Registration

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SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE

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