510(k) Clearances — Page 146
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233779 — LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) | MacroLux Medical Technology Co., Ltd. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232792 — icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) | Icotec AG Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233192 — Wireless Smart Thermometer | Famidoc Technology Company Limited Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232823 — MCG-S (AM1000) | Amcg Co., Ltd. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223914 — ACTIV Cap | Cleansite Medical, Inc. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240360 — Wrinkle Treatment Device (JM2) | Shenzhen Qianyu Technology Co., Ltd. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234152 — ACESO Early Pregnancy Test | Aceso Laboratories, Inc. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230032 — Symani Surgical System | Mmi North America, Inc. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232790 — KONG®-TL VBR System and KONG® C VBR System | Icotec AG Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232114 — TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233837 — Agile Esophageal Stent System | Boston Scientific Corporation Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232227 — ABLATE-IQ | Neuwave Medical, Inc. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240639 — PINNACLETM Constrained Acetabular Liners | Depuy Ireland UC Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240038 — Clear Moves Aligners | Space Maintainers Laboratories (Sml) Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231834 — VSP PEEK Cranial Implant | 3D Systems, Inc. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233026 — Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corporation Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240652 — Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) | Shenzhen Ulike Smart Electronics Co., Ltd. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240071 — Peleton Universal Single Use Power System and Attachments | Peleton Surgical Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240361 — Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233910 — Vertex Hip Fracture Nailing System | Orthoxel Dac Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240172 — Preview Shoulder | Genesis Software Innovations Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | Innovative Health, LLC Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230889 — Digital Thermometer | Wenzhou Yosun Medical Technology Co.,Ltd Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240282 — IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521) | Dongguan Boyuan Intelligent Technology Co.,Ltd Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232653 — Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | Blue Sky Bio, LLC Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240350 — AnyPlus II Spinal Fixation System | GS Medical Co., Ltd. Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233548 — Uresta® | Resilia, Inc. Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240135 — Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | Intuitive Surgical, Inc. Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233618 — Oxevision Sleep Device | Oxehealth Limited Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240618 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232899 — AI-Rad Companion Organs RT | Siemens Medical Solutions U.S.A. Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233975 — Zoom 6F Insert Catheters | Imperative Care, Inc. Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232112 — R&G Surgical Mask | R&G Seguridad E Higiene Industrial S.A.C. Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240888 — Calibra Abutment Resin Cement | Dentsply Sirona Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240601 — SnapshotNIR model KD205 | Kent Imaging, Inc. Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232835 — Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240080 — Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Syntex Healthcare Products Co., Ltd. Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233750 — ECG-less Cardiac | Ge Medical Systems, LLC Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230036 — Sepsis ImmunoScore | Prenosis, Inc. Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K211815 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | Affinity Biosensors Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240397 — AlphaVac MMA F1885 System (H787253020) | AngioDynamics, Inc. Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240043 — EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse | Microport Orthopedics, Inc. Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240635 — ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm | Ximedica Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232726 — External Hex Implant System | Southern Implants (Pty), Ltd. Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233676 — Us2.v2 | Eko.Ai Pte Ltd. D/B/A Us2.Ai Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, | Cefla S.C. Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233990 — Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) | Shandong Xingyu Gloves Co., Ltd. Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233133 — Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |