510(k) Clearances — Page 175
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231764 — Ultrasound System 1300 | Bk Medical Aps Mon Oct 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232561 — Ripley Spinal Screw System by SAGICO | Sagico VA USA, LLC Mon Oct 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231560 — MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | Siemens Medical Solutions USA, Inc. Mon Oct 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232091 — JO Coconut Hybrid Cooling Personal Lubricant | CC Wellness, LLC Sun Oct 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231539 — pRESET LITE Thrombectomy Device | Phenox Limited Sat Oct 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231902 — GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) | Ansell Healthcare Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement | Ulrich Medical USA Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232552 — TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232236 — Echo | Quanta System Spa Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230998 — Digital Wireless Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230983 — Unicare (K-UNICARE-USA) | Tenscare, Ltd. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223557 — SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232922 — Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223909 — R2GATE Lite TM | Megagen Implant Co., Ltd. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231578 — Lucitone Digital Print Denture System | Dentsply Sirona Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233065 — V-PRO maX 2 Low Temperature Sterilization System | Steris Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232042 — NexPort Trocar System (TS211001); NexPort Trocar System (TS211002); NexPort Trocar System (TS211003); NexPort Trocar System (TS211010); NexPort Trocar System (TS211011); NexPort Trocar System (TS211012); NexPort Trocar System (TS221001); NexPort Trocar System (TS221002); NexPort Trocar System (TS221003); NexPort Trocar System (TS221010); NexPort Trocar System (TS221011); NexPort Trocar System (TS221012); NexPort Trocar System (TS221020); NexPort Trocar System (TS221021); | Mediconcepts Technology (Shenzhen) Company Limited Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230209 — Sonix Health | Ontact Health Co., Ltd. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231388 — NextDent Base | Vertex-Dental B.V. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232550 — Nitrile Examination Gloves, Dual Color Black-Blue | Shanxi Hongjin Plastic Technology Co., Ltd. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232951 — BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) | Steris Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232371 — Actinia® hip stems | Implantcast GmbH Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230478 — Acro Composites Interbody System | Acro Composites, LLC Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230178 — EasyOne Sky Spirometer | Ndd Medizintechnik AG Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231381 — Xpert Xpress MVP; GeneXpert Xpress System | Cepheid Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231704 — Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System | Life Spine, Inc. Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231749 — Radio Frequency System | Shenzhenshi Sincoheren S&T Development Co., Ltd. Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230476 — Oran Park Mask | Resmed Pty Ltd (Registration Number: 3004604967) Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231664 — IRRAflow Active Fluid Exchange System (AFES) | Irras USA, Inc. Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230459 — C.C. Life 21 | 21 Equipment S.R.L. Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232484 — KeyLift Expandable Interlaminar Stabilization System | Amplio Spine, LLC Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232910 — CombiDiagnost R90 | Philips Medical Systems Dmc GmbH Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231976 — StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232897 — Arthrex Small External Fixation System | Arthrex, Inc. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231781 — OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230199 — Byte Aligner System | Dentsply Sirona, Inc. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231395 — INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231907 — Medline Safety Insulin and TB Syringes | Medline Industries, LP Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231225 — EConsole1 | DRTECH Corporation Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232123 — MectaLIF Anterior Lag Extension | Medacta International S.A. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231826 — Omnipod 5 ACE Pump | Insulet Corporation Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232924 — T-Line® Hernia Mesh | Deep Blue Medical Advances, Inc. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230951 — Terumo Injection Filter Needle (NF-3013RBKE05M) | Terumo Europe N.V. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232524 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231824 — SmartBolus Calculator | Insulet Corporation Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230702 — Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) | Qingdao Kingon Medical Science and Technology Co., Ltd. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231477 — Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231105 — Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | Shanghai AnQing Medical Instrument Co., Ltd. Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232878 — TransLoc 3D | Foundation Fusion Solutions, LLC (Dba Cornerloc) Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |