510(k) Clearances — Page 101
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242892 — Cristaline Aligners Z FLX | Cristaline Aligners GmbH Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243430 — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243615 — Physica Porous Femoral Components | Lima Corporate S.P.A. Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242216 — GENTAFIX® (1, 3, 3MV) | Teknimed Sas Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242787 — Tens & Ems Device (TU1080) | Changsha Anxiang Medical Technology Co., Ltd. Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242424 — Bluebird Single-Use Respiratory Effort Belt | Cadwell Industries, Inc. Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240959 — Respiratory Muscle Trainer | Chongqing Moffy Innovation Technology Co., Ltd. Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241040 — Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243720 — 3Delta UNlimited | Deltamed GmbH Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243625 — Xpert MRSA/SA SSTI | Cepheid® Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241395 — Active System; Avenue8 | Caerus Corporation Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241095 — ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243128 — Klockner Kits | SOADCO, S.L. Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242535 — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) | Hunan Vathin Medical Instrument Co., Ltd. Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243609 — EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) | Etex Corporation Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240765 — Porous Biologic Scaffold | Ventris Medical Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240763 — FirstFit Surgical Kit | Freudenberg Medical, LLC Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241058 — Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc. Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241132 — ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | Artsmedia Denmark Aps Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242662 — Falcon/Xpress (Falcon/Xpress) | Viasonix , Ltd. Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Böblingen GmbH Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241036 — Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242815 — POCKET TENS (EP-300) | Hivox Biotek, Inc. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240798 — Cntrl+ Bladder Support Pessary | Cntrl+, Inc. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242987 — Thulium Fiber Laser (FiberLAZE+, FiberLAZE) | Allengers Global Healthcare Private Limited Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242413 — VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens | Vizionfocus, Inc. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242146 — BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | Smith & Nephew Medical Limited Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | Healgen Scientific,, LLC Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242558 — Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | O&M Halyard, Inc. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243336 — Lucitone Digital Print Denture System | Dentsply Sirona, Inc. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242816 — Quantium | Bisco, Inc. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241801 — Tornus ES | Asahi Intecc Co., Ltd. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242297 — Reform Pedicle Screw System | Precision Spine, Inc. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241616 — ALLONUS Tech Prosthetics | Allonus Tech Co., Ltd. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242783 — Roche Digital Pathology Dx | Ventana Medical Systems, Inc. Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242869 — prodisc® L Instruments | Centinel Spine, LLC Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243664 — Sentinel Camera | Ai Optics Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243471 — Extraction Basket | Micro-Tech (Nanjing) Co., Ltd. Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240809 — LUOFUCON® Silver Collagen Dressing | Huizhou Foryou Medical Devices Co., Ltd. Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232839 — Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear | Yung Sheng Optical Co., Ltd. Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242015 — TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | DRGEM Corporation Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240937 — AIM (N/A) | Inventeur, LLC Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Aesculap, Inc. Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242307 — ACHIEVE Partial Knee System | Ignite Orthomotion Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240793 — MSKai | Mskai Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240676 — ULTIMUS Series Ultrasound Diagnostic System | Vinno Technology (Suzhou) Co.,Ltd Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243066 — Dental Implants and Abutments | Ditron Dental, Ltd. Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243641 — da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240873 — TEMBO Embolic System | Instylla, Inc. Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |