510(k) Clearances — Page 130
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241111 — AMT Suture Passer | Applied Medical Technology, Inc. Fri Jul 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240252 — UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System | Beckman Coulter, Inc. Fri Jul 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241305 — LifeRay Intraoral Handheld X-ray System | Lucas Lifecare Fri Jul 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241625 — Anatase Navi Disposable Instrument | Remex Medical Corp. Fri Jul 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234082 — STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077) | Advanced Sterilization Products Fri Jul 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234084 — STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count) | Advanced Sterilization Products, Inc. Fri Jul 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241660 — SiOxD® Wound Matrix | Sioxmed, LLC Fri Jul 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241649 — DUO1 and DUO2 | Zinnovi, Inc. Fri Jul 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) | Stryker Sustainability Solutions Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) | Ethicon Endo-Surgery, LLC Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241508 — SKOUT® system | Iterative Scopes, Inc. Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240987 — Access sTfR | Beckman Coulter, Inc. Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241129 — Upper Arm Electronic Blood Pressure Monitor | Shenzhen Goodlymed Technology Co., Ltd. Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240946 — Gastric Alimetry | Alimetry , Ltd. Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241284 — da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240996 — Access Thyroglobulin Antibody II | Beckman Coulter, Inc. Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241577 — Iconix® Anchor | Riverpoint Medical Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240009 — iQFlex Pro | First Source, Inc. Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241615 — Transducer Probe Cover | Hony Medical Co., Ltd. Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241600 — Dermablate | Asclepion Laser Technologies GmbH Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241371 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241277 — OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241591 — Blue Eye | The Standard Co., Ltd. Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233574 — Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240052 — Disposable Enteral Feeding Sets | Beijing L&Z Medical Technology Development Co., Ltd. Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240736 — SMART Bun-Yo-Matic X-Ray | Disior, Ltd. Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240555 — Tyto Insights for Crackles Detection | Tyto Care , Ltd. Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240915 — ZIEN IO Intraosseous Access System | Zien Medical Technologies, Inc. Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234083 — Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233626 — AOS Marker Seeds (SMG0242-025) | Alpha-Omega Services, Inc. Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240930 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue | Sri Trang Gloves Thailand (Public Company Limited) Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234074 — Next Generation Access Catheter | Balt USA, LLC Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233415 — DELTAWAVE Nasal Pillows System | Remsleep Holdings Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240863 — Freedom® Total Knee System | Maxx Orthopedics, Inc. Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241574 — iFuse TORQ® Implant System | SI-BONE, Inc. Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232824 — FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) | Owens & Minor (O&M) Halyard, Inc. Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241300 — ViewPoint 6 | Ge Healthcare GmbH Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241330 — Fogarty Fortis Arterial Embolectomy Catheter | Edwards Lifesciences Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | Philips Medizin Systeme Boeblingen GmbH Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240707 — Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) | Shenzhen Micro Electric Intelligence Co., Ltd. Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240013 — MagDI System | Gt Metabolic Solutions, Inc. Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241622 — Extended Reservoir; MiniMed Reservoir | Medtronic Minimed Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240007 — BioHealx Anal Fistula Device | Signum Surgical Limited Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233477 — Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) | Shandong Wego Ruisheng Medical Device Co., Ltd. Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234061 — StarFormer | Fotona D.O.O. Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232989 — Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) | Shenzhen AOJ Medical Technology Co., Ltd. Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241202 — Electric nasal aspirator (HTD2601US) | Hetaida Technology Co., Ltd. Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232777 — FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) | Owens & Minor (O&M) Halyard, Inc. Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233908 — cNeuro cDAT | Combinostics OY Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241598 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500) | Boston Scientific Corporation Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |