510(k) Clearances — Page 76
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | Zeus Scientific Wed May 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241980 — !M1 | Solutions For Tomorrow AB Tue May 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250785 — Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. Tue May 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251094 — Alma Veil | Wontech Co., Ltd. Tue May 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250160 — ANKYRAS | Mentice Spain S.L. Tue May 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243017 — IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) | Foshan Newface Electronic Technology Co., Ltd. Tue May 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250253 — IPL Hair Removal Device (KCA511/KCA516/KCA522) | Dongguan Boyuan Intelligent Technology Co.,Ltd Tue May 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240447 — ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | Thermasolutions, LLC Mon May 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242962 — Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH Mon May 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242754 — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical D.O.O. Mon May 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242386 — Bluemoon | Genoss Co., Ltd. Mon May 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243603 — AeviceMD | Aevice Health Pte. , Ltd. Mon May 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250728 — Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. Mon May 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243370 — DentaTOOTH | Asiga Pty, Ltd. Mon May 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242937 — Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) Mon May 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243893 — Second Opinion® Pediatric | Pearl, Inc. Mon May 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244001 — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) | Karl Storz SE & CO. KG Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243069 — LUMYS (V1) | Intradys Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250292 — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | Skydance Vascular, Inc. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242763 — JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243894 — F88 URE-SD/RD Flexible Ureteroscope | Sg Endoscopy Pte, Ltd. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242986 — SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243828 — CIONIC NEURAL SLEEVE (NS-200) | Cionic, Inc. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251056 — Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251071 — Fetal EchoScan (v1.1) | Brightheart Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250629 — Sutil Rich Personal Lubricant | Hathor Professional Skincare , Ltd. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243757 — Shockwave CS Guide Catheter | Shockwave Medical, Inc. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242583 — AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243114 — SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243043 — Origin Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250161 — Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo | Shenzhen AOJ Medical Technology Co., Ltd. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243457 — Nixall Antimicrobial Solutions Skin & Wound Hydrogel | Seriously Clean, Ltd. Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242315 — Resolve Modular Revision Hip Stem | United Orthopedic Corporation Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250029 — ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250087 — Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250296 — Disposable Distal Attachment D-201 Series | Olympus Medical Systems Corp. Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251014 — APRO 45 Catheter | Alembic, LLC Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | Circa Scientific, Inc. Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250996 — Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250641 — APEX 3D Total Ankle Replacement System | Paragon 28, Inc. Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250995 — Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243870 — X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies, Inc. Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244020 — Wrinkle Treatment Device (JM1, JM2B) | Shenzhen Qianyu Technology Co., Ltd. Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243521 — Conical Ti Base abutments | BioHorizons Implant Systems, Inc. Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251015 — APRO 45 Catheter and Alembic Aspiration Tubing | Alembic, LLC Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251051 — AuST Steerable Sheath | CenterPoint Systems, LLC Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250295 — Dentsply Sirona Titanium Bases system | Dentsply Sirona Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250497 — Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd. Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |