510(k) Clearances

174,759 clearances total

K223533 — Little Wave Arc; Little Wave FlipKi Mobility, LLC Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K213271 — MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis Medical Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232353 — Powder Free Nitrile Examination Gloves (Black)Shanxi Hongjin Plastic Technology Co., Ltd. Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230488 — EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231978 — BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50Vivachek Biotech (Hangzhou) Co., Ltd. Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231323 — Ancora-SBAspero Medical, Inc. Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd. Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222563 — BD Kiestra IdentifABecton, Dickinson and Company Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221959 — Q21Neurofield, Inc. Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231433 — The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mLThermo Fisher Scientific Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus Scientific Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223527 — Little Wave Clik, Rogue XP, Little Wave XP, SparkKi Mobility, LLC Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232287 — RAYSCAN a-Expert3DRay Co., Ltd. Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223597 — 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)23AndMe, Inc. Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231246 — Ventrax™ Delivery System (VTR851)Merit Medical Systems, Inc. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223303 — Spinery™ RF Ablation SystemAxon Spine Medical System Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230355 — Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232324 — StealthFix Intraosseous Fixation SystemMedartis, Inc. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223468 — Nexis® compressive screwsNovastep Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231093 — AlphaVent Suture AnchorsStryker Endoscopy Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231156 — Enzyme Packed Cartridge - RELiZORBAlcresta Therapeutics, Inc. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K213418 — MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223130 — Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)Covidien Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230013 — Silk'n Titan AllwaysSilk'N Beauty , Ltd. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)Teleflex Medical Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231961 — NIBPCuffShenzhen Sino-K Medical Technology Co.,Ltd Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232295 — LAA Exclusion SystemSyntheon, LLC Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231580 — NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)Medtronic Xomed, Inc. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231988 — Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/mlThermo Fisher Scientific Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231024 — AquaBeam Robotic SystemProcept Biorobotics, Corporation Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223367 — Ochsner Connected Inhaler SensorOchsner Clinic Foundation Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231289 — S-Patch Ex Wearable ECG PatchWellysis Corp. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231123 — Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231656 — Brainomix 360 e-MRIBrainomix Limited Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231276 — SmartCardia 7L PlatformSmartcardia SA Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232343 — AC3™ Series IABPArrow International, LLC Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230155 — Mick Valencia Applicator SetMick Radio-Nuclear Instruments, Inc. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232226 — ARROW Off-Centred Humeral InsertFH Industrie Tue Aug 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232313 — LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)Ethicon Endo Surgery, LLC Tue Aug 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221361 — circul™ pro RingBodimetrics, LLC Tue Aug 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231407 — StarFinPremium Medical Technology, LLC Tue Aug 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230765 — Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. Tue Aug 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231676 — CALLISTO eyeCarl Zeiss Meditec, AG Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232387 — Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231422 — Precision GILimaca Medical, Ltd. Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223639 — VisAble.IOTechsomed Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231537 — SofWave SystemSofwave Medical, Ltd. Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230159 — SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc. Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231623 — Distal Elbow Plating SystemSkeletal Dynamics, Inc. Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231435 — KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric AcidKimberly-Clark Corporation Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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