510(k) Clearances in 2023 — Page 25

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 25 of 67)
510(k) clearancesDetails
K231611 — HOLO Portal™ Surgical Guidance SystemSurgalign Spine Technologies Aug 31, 2023
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. Aug 31, 2023
K231323 — Ancora-SBAspero Medical, Inc. Aug 31, 2023
K230488 — EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH Aug 31, 2023
K221959 — Q21Neurofield, Inc. Aug 31, 2023
K231433 — The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mLThermo Fisher Scientific Aug 31, 2023
K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus Scientific Aug 31, 2023
K223527 — Little Wave Clik, Rogue XP, Little Wave XP, SparkKi Mobility, LLC Aug 31, 2023
K223597 — 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)23AndMe, Inc. Aug 31, 2023
K223303 — Spinery™ RF Ablation SystemAxon Spine Medical System Aug 30, 2023
K232324 — StealthFix Intraosseous Fixation SystemMedartis, Inc. Aug 30, 2023
K231156 — Enzyme Packed Cartridge - RELiZORBAlcresta Therapeutics, Inc. Aug 30, 2023
K231246 — Ventrax™ Delivery System (VTR851)Merit Medical Systems, Inc. Aug 30, 2023
K230013 — Silk'n Titan AllwaysSilk'N Beauty , Ltd. Aug 30, 2023
K230355 — Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Aug 30, 2023
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 Aug 30, 2023
K231093 — AlphaVent Suture AnchorsStryker Endoscopy Aug 30, 2023
K232343 — AC3™ Series IABPArrow International, LLC Aug 30, 2023
K223468 — Nexis® compressive screwsNovastep Aug 30, 2023
K223130 — Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)Covidien Aug 30, 2023
K231289 — S-Patch Ex Wearable ECG PatchWellysis Corp. Aug 30, 2023
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. Aug 30, 2023
K231961 — NIBPCuffShenzhen Sino-K Medical Technology Co.,Ltd Aug 30, 2023
K213418 — MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. Aug 30, 2023
K232295 — LAA Exclusion SystemSyntheon, LLC Aug 30, 2023
K231580 — NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)Medtronic Xomed, Inc. Aug 30, 2023
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 Aug 30, 2023
K231024 — AquaBeam Robotic SystemProcept Biorobotics, Corporation Aug 30, 2023
K223367 — Ochsner Connected Inhaler SensorOchsner Clinic Foundation Aug 30, 2023
K231656 — Brainomix 360 e-MRIBrainomix Limited Aug 30, 2023
K231276 — SmartCardia 7L PlatformSmartcardia SA Aug 30, 2023
K230155 — Mick Valencia Applicator SetMick Radio-Nuclear Instruments, Inc. Aug 30, 2023
K232313 — LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)Ethicon Endo Surgery, LLC Aug 29, 2023
K232226 — ARROW Off-Centred Humeral InsertFH Industrie Aug 29, 2023
K221361 — circul™ pro RingBodimetrics, LLC Aug 29, 2023
K231407 — StarFinPremium Medical Technology, LLC Aug 29, 2023
K230765 — Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. Aug 29, 2023
K232387 — Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts Aug 28, 2023
K223639 — VisAble.IOTechsomed Aug 28, 2023
K231422 — Precision GILimaca Medical, Ltd. Aug 28, 2023
K230221 — QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics And Radiation Safety Aug 28, 2023
K231676 — CALLISTO eyeCarl Zeiss Meditec, AG Aug 28, 2023
K231537 — SofWave SystemSofwave Medical, Ltd. Aug 28, 2023
K230159 — SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc. Aug 28, 2023
K231623 — Distal Elbow Plating SystemSkeletal Dynamics, Inc. Aug 28, 2023
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 Aug 28, 2023
K222525 — Alveoair Digital SpirometerRoundworks Technologies Private Limited Aug 28, 2023
K223727 — LavieenWontech Co., Ltd. Aug 25, 2023
K222972 — BioProtect Balloon Implant™ SystemBioprotect, Ltd. Aug 25, 2023
K223180 — AIRAscoreAiramed GmbH Aug 25, 2023
← Previous Page 25 of 67 Next →