510(k) Clearances — Page 185
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231047 — UniSyn Molecular Imaging (6-3-1) | Convergent Imaging Solutions Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232014 — CONDUIT ATP Inserters | Enztec Limited Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230007 — LightStrike+ (MXSUV1-SL and MXSUV1-FT) | Xenex Disinfection Services, Inc. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232021 — Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | Philips Healthcare (Suzhou) Co., Ltd. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232657 — InnerView LC | Perimetrics, Inc. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230623 — KITE Distal Fibula Kit | Intrauma S.P.A Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221601 — MS-39 | C.S.O. S.R.L. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231710 — OW100S | Softwave/Trt, LLC Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223533 — Little Wave Arc; Little Wave Flip | Ki Mobility, LLC Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231626 — OSPREY Closed IV Catheter System (OspreyV2) | Skydance Vascular, Inc. Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213271 — MedicloseTM System | Health Value Creation B.V., Trading AS Corporis Medical 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 Fentanyl | Wrp Asia Pacific Sdn. Bhd. Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232287 — RAYSCAN a-Expert3D | Ray Co., Ltd. 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 50 | Vivachek Biotech (Hangzhou) Co., Ltd. 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) |
| K231323 — Ancora-SB | Aspero Medical, Inc. Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231611 — HOLO Portal Surgical Guidance System | Surgalign Spine Technologies Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230488 — EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222563 — BD Kiestra IdentifA | Becton, Dickinson and Company Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221959 — Q21 | Neurofield, 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/mL | Thermo Fisher Scientific Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | Zeus Scientific Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223527 — Little Wave Clik, Rogue XP, Little Wave XP, Spark | Ki Mobility, LLC 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) |
| K231156 — Enzyme Packed Cartridge - RELiZORB | Alcresta Therapeutics, Inc. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230013 — Silk'n Titan Allways | Silk'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) |
| K232324 — StealthFix Intraosseous Fixation System | Medartis, Inc. Wed Aug 30 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 System | Axon Spine Medical System Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231289 — S-Patch Ex Wearable ECG Patch | Wellysis Corp. 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 MR | Canon Medical Systems Corporation Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231093 — AlphaVent Suture Anchors | Stryker Endoscopy Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223468 — Nexis® compressive screws | Novastep 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) |
| K232343 — AC3 Series IABP | Arrow International, LLC 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) |
| K231961 — NIBPCuff | Shenzhen Sino-K Medical Technology Co.,Ltd Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213418 — MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232295 — LAA Exclusion System | Syntheon, 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/ml | Thermo Fisher Scientific Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231024 — AquaBeam Robotic System | Procept Biorobotics, Corporation Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223367 — Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231656 — Brainomix 360 e-MRI | Brainomix Limited Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231276 — SmartCardia 7L Platform | Smartcardia SA Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230155 — Mick Valencia Applicator Set | Mick Radio-Nuclear Instruments, Inc. Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232226 — ARROW Off-Centred Humeral Insert | FH 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 Ring | Bodimetrics, LLC Tue Aug 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |