510(k) Clearances — Page 187
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K212766 — Maxiocel Chitosan Wound Dressing | Advamedica, Inc. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack | Ortho Clinical Diagnostics Wed Aug 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232243 — EVO 700 series high speed handpiece | Ttbio Corp. Wed Aug 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230812 — Withings Scan Monitor 2.0 | Withings Wed Aug 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | Ansell Healthcare Products, LLC Wed Aug 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222946 — Oneday Mini Implant System | Oneday Biotech Co., Ltd. Wed Aug 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223590 — Access Folate Assay | Beckman Coulter, Inc. Wed Aug 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230610 — Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) | Dongguan Shin YI Healthcare Products Factory Wed Aug 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223574 — IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) | Philips Medizin Systeme Boeblingen GmbH Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231503 — CUPTIMIZE Advanced | DePuy Orthopaedics, Inc. Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232190 — 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter | Medtronic Vascular Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231205 — GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray | Gurunanda, LLC Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231510 — Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | Xiantao Zhibo Non-Woven Products Co., Ltd. Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220052 — BrachyGel Vaginal Hydrogel Packing System | Brachyfoam, Inc. D/B/A Advaray Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231811 — Zavation Connector System | Zavation Medical Products, LLC Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231496 — TITAN 3-D Wedge System | Paragon 28, Inc. Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230899 — qXR-PTX-PE | Qure.Ai Technologies Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220938 — Nova HD+ | Aura Wellness, LLC Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231731 — Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 | Mcgovern Medical School Mon Aug 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223813 — Aveta System 2.0 | Meditrina, Inc. Mon Aug 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232185 — SM-IV | Sedecal., Sa. Mon Aug 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230486 — Cove Strip | SeaSpine Orthopedics Corporation Mon Aug 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231763 — Stable-C Interbody System | Nexus Spine, LLC Mon Aug 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231867 — Grappler Suture Anchor System | Paragon 28, Inc. Mon Aug 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222245 — ACR Screw System | Biomaterials Korea, Inc. Mon Aug 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223560 — Plato 17 Microcatheter | Scientia Vascular, Inc. Mon Aug 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231266 — Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. Mon Aug 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp Sat Aug 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223883 — Daye Tampon | Annes Daye, Ltd. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232144 — Sterile Products of the APTUS System | Medartis AG Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231257 — Pangea Utility Plating System, Pangea Platform | Stryker GmbH Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231096 — Automatic Continuous Effusion Shunt (ACES) System ACES System | Pleural Dynamics, Inc. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231457 — SPARK Scan | Spark Neuro, Inc. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231085 — 1.5T HD T/R Knee Array (10-F34127) | Shenzhen RF Tech Co., Ltd. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | Olympus Winter & Ibe GmbH Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220253 — Eco Abutment, Multiunit Abutment | Dio Corporation Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223539 — Dreem 3S | Beacon Biosignals, Inc. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231026 — 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) | Shenzhen Beacon Display Technology Co., Ltd. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230579 — Smart Wedge algorithm | Edwards Lifesciences, LLC Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231262 — Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System | Stryker GmbH Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231204 — Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App | Cochlear Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230019 — AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) | Boston Scientific Corporation Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231718 — Holmium Medical Laser | Allengers Global Healthcare Private Limited Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232150 — ZSFab Cervical Interbody System | Zsfab, Inc. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231053 — Unicare (K-UNICARE-USA) | Tenscare, Ltd. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | Ultradent Product, Inc. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223526 — ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing | Smith & Nephew Medical Limited Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223867 — IDS ACTH II | Immunodiagnostic Systems Limited Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232153 — Avéli | Revelle Aesthetics, Inc. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231673 — P200TE (A10700) | Optos Plc. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |