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Available for immediate download.
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FDA 510(k) K233199, ROSA® Shoulder System, by Orthosoft Inc (D/B/A Zimmer Cas)
Regular price $1,121.06 USDRegular priceUnit price / per -
FDA 510(k) K233253, eCARTv5 Clinical Deterioration Suite (“eCART”), by Agilemd, Inc.
Regular price $969.16 USDRegular priceUnit price / per -
FDA 510(k) K233590, Overjet Charting Assist, by Overjet, Inc.
Regular price $1,674.40 USDRegular priceUnit price / per -
FDA 510(k) K233700, Avicenna Roboflex, by Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi
Regular price $1,980.00 USDRegular priceUnit price / per -
FDA 510(k) K233991, CanGaroo RM Antibacterial Envelope, by Elutia, Inc.
Regular price $853.43 USDRegular priceUnit price / per -
FDA 510(k) K234027, embecta Insulin Delivery System, by Embecta Medical I, LLC
Regular price $3,500.00 USDRegular priceUnit price / per -
FDA 510(k) K234055, DEKA Loop, by Deka Research and Development
Regular price $1,952.87 USDRegular priceUnit price / per -
FDA 510(k) K240011, Lymphedema Compression, by Jkh Health Co., Ltd.
Regular price $477.30 USDRegular priceUnit price / per -
FDA 510(k) K240044, CADDIE, by Odin Medical Limited
Regular price $1,652.70 USDRegular priceUnit price / per -
FDA 510(k) K240062, ARVIS® Shoulder, by Insight Medical Systems, Inc.
Regular price $1,021.60 USDRegular priceUnit price / per -
FDA 510(k) K240117, Aventus Thrombectomy System (IM-2001/IM-0002), by Inquis Medical
Regular price $705.15 USDRegular priceUnit price / per -
FDA 510(k) K240285, Huxley SANSA Home Sleep Apnea Test (1000-00), by Huxley Medical
Regular price $2,242.20 USDRegular priceUnit price / per -
FDA 510(k) K240376, Electroporation System (N3000), by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Regular price $3,464.61 USDRegular priceUnit price / per -
FDA 510(k) K240426, Aventus Clot Management System, by Inquis Medical
Regular price $817.26 USDRegular priceUnit price / per -
FDA 510(k) K240597, TERA HARZ CLEAR, by Graphy, Inc.
Regular price $607.50 USDRegular priceUnit price / per -
FDA 510(k) K240624, InfuLife, by First Medical Source, LLC
Regular price $766.63 USDRegular priceUnit price / per -
FDA 510(k) K240776, Celsio Flexible Cryocatheter System, by Endocision Technologies, Inc.
Regular price $1,211.47 USDRegular priceUnit price / per -
FDA 510(k) K240867, cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems, by Roche Molecular Systems, Inc.
Regular price $3,500.00 USDRegular priceUnit price / per -
FDA 510(k) K241071, NextDent Jet Denture Base; NextDent Jet Denture Teeth, by Vertex-Dental B.V.
Regular price $1,005.32 USDRegular priceUnit price / per -
FDA 510(k) K241108, RemedyLogic AI MRI Lumbar Spine Reader, by Remedy Logic, Inc.
Regular price $1,573.13 USDRegular priceUnit price / per -
FDA 510(k) K241168, System 83 Revolve Endoscope Washer/Disinfector, by Wassenburg Medical, Inc.
Regular price $1,985.42 USDRegular priceUnit price / per -
FDA 510(k) K241169, Entarik NI Feeding Tube System, by Gravitas Medical, Inc.
Regular price $1,258.49 USDRegular priceUnit price / per -
FDA 510(k) K241211, CoLumbo, by Smart Soft Healthcare
Regular price $914.91 USDRegular priceUnit price / per -
FDA 510(k) K241488, TrainFES Advance, by Trainfes
Regular price $1,589.41 USDRegular priceUnit price / per -
FDA 510(k) K241872, Remanufactured EndoWrist ProGrasp Forceps (420093), by Rebotix
Regular price $815.45 USDRegular priceUnit price / per -
FDA 510(k) K242076, VersaCross™ RF Wire, by Baylis Medical Company
Regular price $788.33 USDRegular priceUnit price / per -
FDA 510(k) K242086, MagDI System (MAG-01, DS-01), by Gt Metabolic Solutions, Inc.
Regular price $1,225.94 USDRegular priceUnit price / per -
FDA 510(k) K242152, SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141), by Epic Medical Pte. , Ltd.
Regular price $699.72 USDRegular priceUnit price / per -
FDA 510(k) K242382, décoLITE LED Device, by iSMART Developments, Ltd.
Regular price $741.31 USDRegular priceUnit price / per -
FDA 510(k) K242473, Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562), by Coloplast Corp.
Regular price $1,108.40 USDRegular priceUnit price / per -
FDA 510(k) K242604, Helios+ UV-C System, by Preventamed Technologies, Inc. Dba Surfacide Manufacturing
Regular price $2,898.61 USDRegular priceUnit price / per -
FDA 510(k) K242610, 8mm Monopolar Curved Scissors (470179), by Iconocare Health
Regular price $3,500.00 USDRegular priceUnit price / per -
FDA 510(k) K242913, Jasmate® Toothpaste, by Jasberry Healthcare Private Limited
Regular price $3,482.70 USDRegular priceUnit price / per -
FDA 510(k) K243213, Self-Forming Magnet (FLEX SFM), by GI Windows, Inc.
Regular price $1,366.98 USDRegular priceUnit price / per -
FDA 510(k) K243442, iBOT® PMD, by Mobius Mobility
Regular price $3,500.00 USDRegular priceUnit price / per -
FDA 510(k) K243750, SimpleStitch Suturing System, by Envision Endoscopy
Regular price $1,086.70 USDRegular priceUnit price / per