510(k) Clearances

174,759 clearances total

K240374 — Ureterorenoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240708 — Organic Cotton Tampon; Organic Cotton PESCVcord TamponSuzhou Borage Medical Technology Co., Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232475 — Disposable infusion set with needleShandong Zhushi Pharmaceutical Group Co., Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardGuangzhou Decheng Biotechnology Co., Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234112 — Customized AbutmentArum Dentistry Co., Ltd. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233967 — DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240296 — Tulsa Pro System (Pad-105)Profound Medical, Inc. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232470 — Polyisoprene Extra Large CondomSuretex Limited Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232025 — Hushd Pro AveraGood Sleep CO Pte , Ltd. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233418 — Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233602 — P200TE (A10700)Optos Plc. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240495 — Flexible Fixation Device for Gynecological Applicators (GM11001960)Varian Medical Systems, Inc. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232976 — VUZE SystemVuze Medical , Ltd. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233918 — Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232477 — Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)Jiangxi AOV Maternity & Baby Products Co., Ltd. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233982 — CEREGLIDE 92 Catheter SystemCerenovus, Inc. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232468 — SC Medica FFXSc Medica Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240403 — Access BR MonitorBeckman Coulter, Inc. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240964 — FLOW 90? WandArthroCare Corporation Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241008 — Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)Relign Corporation, Subsidiary of Zimmer Biomet Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233803 — UltraClear Laser System (N/A)Acclaro Corporation Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K222292 — F&P myAirvo 3Fisher & Paykel Healthcare Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240999 — Legend X Applicator VOPollogen, Ltd. Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232649 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233695 — Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240377 — LIFEPAK® ECG CablesStryker Physio-Control Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)Wuhan Huchuang Union Technology Co., Ltd. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234018 — CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234039 — AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)Lexington Medical, Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233766 — Geneo X ElitePollogen, Ltd. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231612 — Eve Patient Positioner SystemLeo Cancer Care Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232928 — DeepContour (V1.0)Wisdom Technologies., Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233864 — ASSURE Wearable ECGKestra Medical Technologies, Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232833 — HALO AP DxIndica Labs, Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232486 — KARL STORZ Monopolar Resectoscopes with HF CableKarl Storz SE & CO. KG Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232514 — MIM – Dose AnalysisMim Software, Inc. Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240392 — JAZZ Spinal SystemImplanet Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240007 — Solar Compact (G4-1)Laborie Medical Technologies, Corp. Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240685 — Salvo® Spine SystemSpine Wave, Inc. Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233800 — Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc. Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)Boehringer Laboratories, LLC Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232454 — Viral Transport Media (VTM)Alb Luz Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233157 — VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233687 — ECHELON Synergy V10.0FUJIFILM Healthcare Americas Corporation Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232735 — EMA 3DEma Sleep Incorporated Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240126 — ProAM ALIF SystemPro Surgical, Inc. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234088 — Emily's Care Nourish Test System (Model 1)Lactation Lab, Inc. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233349 — Alinity m HSV 1 & 2 / VZVAbbott Molecular, Inc. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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