510(k) Clearances — Page 140
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240276 — PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software | Given Imaging Ltd. (D.B.A. Medtronic) Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | Guangzhou Decheng Biotechnology Co., Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233100 — QIAstat-Dx® Respiratory Panel Plus | QIAGEN GmbH Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240479 — Access OV Monitor | Beckman Coulter, Inc. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240699 — SCARLET® AC-Ti | Spineart SA Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233277 — Filter Needle for Single Use | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240365 — Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234079 — HyperSuture Extension Line | Threadstone, LLC Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232507 — Aerogen®Solo Nebulizer System | Aerogen, Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232410 — SmartChest | Milvue Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233629 — APERTO Lucent MRI System | FUJIFILM Healthcare Americas Corporation Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240374 — Ureterorenoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240708 — Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | Suzhou Borage Medical Technology Co., Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232475 — Disposable infusion set with needle | Shandong Zhushi Pharmaceutical Group Co., Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240296 — Tulsa Pro System (Pad-105) | Profound Medical, Inc. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234112 — Customized Abutment | Arum Dentistry Co., Ltd. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233967 — DePuy Synthes MatrixSTERNUM Fixation System | Synthes GmbH Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233918 — Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232470 — Polyisoprene Extra Large Condom | Suretex Limited Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232477 — Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) | Jiangxi AOV Maternity & Baby Products Co., Ltd. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232025 — Hushd Pro Avera | Good Sleep CO Pte , Ltd. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233418 — Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233602 — P200TE (A10700) | Optos Plc. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240495 — Flexible Fixation Device for Gynecological Applicators (GM11001960) | Varian Medical Systems, Inc. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232976 — VUZE System | Vuze Medical , Ltd. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233982 — CEREGLIDE 92 Catheter System | Cerenovus, Inc. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232468 — SC Medica FFX | Sc Medica Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240403 — Access BR Monitor | Beckman Coulter, Inc. Thu May 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240964 — FLOW 90? Wand | ArthroCare Corporation Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241008 — Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027) | Relign Corporation, Subsidiary of Zimmer Biomet Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233803 — UltraClear Laser System (N/A) | Acclaro Corporation Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222292 — F&P myAirvo 3 | Fisher & Paykel Healthcare Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240999 — Legend X Applicator VO | Pollogen, Ltd. Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232649 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234018 — CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System | Dentsply Sirona Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233695 — Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne, Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233766 — Geneo X Elite | Pollogen, Ltd. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232486 — KARL STORZ Monopolar Resectoscopes with HF Cable | Karl Storz SE & CO. KG Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) | Wuhan Huchuang Union Technology Co., Ltd. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240377 — LIFEPAK® ECG Cables | Stryker Physio-Control Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234039 — AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) | Lexington Medical, Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231612 — Eve Patient Positioner System | Leo Cancer Care Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232928 — DeepContour (V1.0) | Wisdom Technologies., Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233864 — ASSURE Wearable ECG | Kestra Medical Technologies, Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232833 — HALO AP Dx | Indica Labs, Inc. Tue May 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232514 — MIM Dose Analysis | Mim Software, Inc. Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240392 — JAZZ Spinal System | Implanet Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240007 — Solar Compact (G4-1) | Laborie Medical Technologies, Corp. Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |