510(k) Clearances — Page 148
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231793 — RODIN 3D Resin SPLINT, Hard/Flex | Belport Company, Inc., Gingi-Pak Tue Mar 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233611 — SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) | Maine Molecular Quality Controls, Inc. Tue Mar 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233151 — PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) | Medline Industries, LP Tue Mar 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231132 — J & P Click Attachments | J & P Dental Technologies Tue Mar 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231984 — Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) | Shenzhen Hingmed Medical Instrument Co., Ltd. Tue Mar 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233069 — Removal System Large Bore 60 cc Syringe | Inari Medical, Inc. Tue Mar 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233650 — SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. Tue Mar 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233733 — SyMRI | Syntheticmr AB (Publ.) Tue Mar 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233167 — LW Implant System Abutment | Ossvis Co., Ltd. Mon Mar 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240620 — Cube Navigator | Medical Templates AG Mon Mar 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233275 — RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) | Gyrus Acmi, Inc. Mon Mar 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240589 — Micropuncture Introducer Sets; Micropuncture Pedal Access Sets | Cook Medical Mon Mar 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234085 — LUNE PureHygiene | Enamel Pure Mon Mar 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232268 — STERI-OSS Implant System | Zeros Co., Ltd. Mon Mar 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233919 — VariAx 2 Distal Radius System | Stryker GmbH Mon Mar 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | Soterix Medical, Inc. Mon Mar 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240292 — Transcutaneous Electrical Nerve Stimulator (9029SCM) | Hong Kong Etech Groups Limited Mon Mar 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240329 — Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F) | Yongkang Youha Electric Appliance Co., Ltd. Mon Mar 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231986 — Modus IR | Synaptive Medical, Inc. Mon Mar 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240690 — STRUXXURE® MCS Anterior Cervical Plate System | Nexxt Spine Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231927 — Elecsys PTH , Elecsys PTH STAT | Roche Diagnostics Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231930 — Digital Ultrasonic Diagnostic Imaging System (Model: F6) | Guangdong Youkey Medical Co., Ltd. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230034 — X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application | Scopio Labs , Ltd. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233262 — Dukal SMS Sterilization Wrap | Dukal, LLC Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232920 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | Ureteral Stent Company Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233148 — Augment Off-Axis Instrument System | Fix Surgical Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231926 — NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232169 — FITBONE® Transport and Lengthening System | Orthofix Srl Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector | Medivators (A Subsidiary of Steris Corporation) Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233578 — BAHADIR STERILIZATION CONTAINERS | Bahadir USA, LLC Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232322 — MAGNETOM Terra; MAGNETOM Terra.X | Siemens Medical Solutions USA, Inc. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240225 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232282 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231806 — Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | Oxoid Limited (Part of Thermo Fisher Scientific) Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232431 — syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240540 — uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231938 — Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | O&M Halyard, Inc. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231953 — Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) | Coloplast Corp. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231795 — QuickVue COVID-19 Test | Quidel Corporation Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240715 — Idys® C ZP 3DTi | Clariance Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | Murata Vios, Inc. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233569 — SeptAlign | Spirair, Inc. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233441 — The Vest APX System (PVAPX1) | Baxter Healthcare Corportation Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232548 — Corsano CardioWatch 287-2 System | Corsano Health B.V. Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233713 — Pilling Tracheostomy Tubes | Teleflex Medical Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240522 — Esophageal TTS Stent | Taewoong Medical Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240122 — Normatec Elite | NormaTec Industries, LP Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240253 — Reach Needle | Aerin Medical, Inc. Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240309 — Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233980 — ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System | Depuy Ireland UC Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |