510(k) Clearances — Page 71
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250024 — TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242751 — ARIX Pectus Bar System | Jeil Medical Corporation Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242635 — Endoscopic Distal Attachment (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250637 — VCFix Spinal System | Amber Implants Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240047 — Allix5 | Clairity, Inc. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243654 — DentalJect | Vapocoolshot, Inc. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250078 — Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) | Mindset Medical, Inc. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243005 — AudaxCeph Cephalogram Analysis Software | Audax D.O.O. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250150 — VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) | Sorin Group Italia S.R.L. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242830 — LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250581 — KALA Red Light Face Mask (KALA-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241313 — OHC COVID-19 Antigen Self Test | Osang, LLC Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce | Owens & Minor (O&M) Halyard, Inc. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250195 — MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) | Matelaser, Inc. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251406 — BriefCase-Triage | Aidoc Medical , Ltd. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250317 — EsFlow PLUS | Spident Co., Ltd. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250368 — Wearable Breast Pump (Model S21) | Shenzhen TPH Technology Co., Ltd. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243863 — Opulus Lymphoma Precision | Roche Molecular Systems, Inc. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250365 — Motif Aura Glow breast pump (Model Motif Aura Glow) | Shenzhen TPH Technology Co., Ltd. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243522 — ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243530 — Dynamic TiBase | Talladium España, SL Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250236 — Swoop® Portable MR Imaging® System (V2) | Hyperfine, Inc. Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251383 — Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242640 — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | Fertipro NV Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250543 — Voluson Performance 16; Voluson Performance 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243497 — Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US | Shanghai AnQing Medical Instrument Co., Ltd. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243372 — BiliWrap | Gerium Medical, Ltd. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250606 — Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250757 — Radius VSM and Accessories | Masimo Corporation Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250673 — CERABIEN MiLai | Kuraray Noritake Dental, Inc. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250215 — Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | Cochlear Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422) | Medtronic Navigation Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243856 — TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) | Shenzhen Astec Technology Co., Ltd. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250048 — NEUROMARK System (NMK00301) | Neurent Medical , Ltd. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240048 — Spur Peripheral Retrievable Stent System | Reflow Medical, Inc. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251315 — Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II | Remex Medical Corp. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243480 — SuturePatch Tissue Reinforcement | Arthrex, Inc. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243484 — PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251340 — ProSeal Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte. , Ltd. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251325 — VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243469 — SIGNEX | Osteonic Co., Ltd. Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242752 — MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242699 — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) | Opcom Medical, Inc. Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243716 — Zionic Pro Max (Radiofrequency) | Termosalud S.L. Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250624 — myAir | Resmed Corp Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250367 — CoLumboX | Smart Soft Healthcare AD Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243047 — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | Imperative Care, Inc. Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243949 — OsteoFlo HydroFiber | SurGenTec, LLC Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244049 — Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |