510(k) Clearances — Page 134
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241082 — INNOVERSE Navigation Instruments | Innosys Co., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240721 — ExcelsiusFlex | Globus Medical, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233955 — Clarius OB AI | Clarius Mobile Health Corp. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240729 — Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61) | Shenzhen Pango Medical Electronics Co., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233254 — TELIGEN System Navigation Ready Instruments | DePuy Synthes Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233991 — CanGaroo RM Antibacterial Envelope | Elutia, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233496 — EndeavorOTC | Akili Interactive Labs, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241250 — 3DMax Light Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233043 — Smart Scope® CX | Periwinkle Technologies Pvt., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) | Contec Medical Systems Co.,Ltd Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240124 — BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233079 — Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) | Cook Ireland, Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232879 — Roche Digital Pathology Dx (VENTANA DP 200) | Ventana Medical Systems, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240696 — Airdog X8 Air Purifier (KJ800F-X8) | Suzhou Beiang Smart Technology Co., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240817 — VersaWrap | Alafair Biosciences, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240460 — FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) | FMD Co., Ltd. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233821 — F&P Optiflow Oxygen Kit (AA451J) | Fisher & Paykel Healthcare, Ltd. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232953 — AquaBplus; AquaB LITE | Fresenius Medical Care Renal Therapies Group, LLC Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233662 — Radiography 7300 C | Philips Medical Systems Dmc GmbH Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232930 — VERVE | Oculomotor Technologies Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241499 — 21.3 5MP Color LCD Display UMD5-21B01 | Acula Technology Corp. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240815 — Arthrex Cannulated Screw System | Arthrex, Inc. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233321 — Double Balloon Endoscope EN-840T, Over-tube TS-1214C | FUJIFILM Healthcare Americas Corporation Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233925 — Relu Creator | Relu BV Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240017 — InMode System with the Morpheus8 90 Applicator | InMode , Ltd. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241370 — Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) | ABBOTT MEDICAL Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241358 — BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E | Sun Pharmaceutical Industries, Inc. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233892 — 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) | Zhuhai Dipu Medical Technology Co., Ltd. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240149 — Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium | Gimbo Medical Technology Shenzhen Co., Ltd. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231060 — ProMin Dental Desensitizing Gel | Belport Company, Inc., Gingi-Pak Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241352 — Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | Medtronic, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | Medacta International S.A. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240876 — Identity Shoulder System | Zimmer, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233266 — MEDIBLU ECG SYSTEM | Mediblu Medical, LLC Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240050 — SOUNDSTAR CRYSTAL Ultrasound Catheter | Biosense Webster, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240910 — EO Chex Indicator Tape | Propper Manufacturing Co., Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240516 — RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | bioMerieux, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232950 — Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle | Perfect Medical Industry (Vn) Co., Ltd. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233007 — Picosecond Nd:YAG Laser System; PICO LEGEND | Ami, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240256 — Remunity System | Deka Research and Development Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233610 — ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System | Siemens Medical Solutions USA, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240504 — PLASMA EDGE System | Lamidey Noury Medical Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233613 — ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221547 — InActiv Blue | Fertipro NV Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241344 — MetriCide OPA Plus Solution Test Strip | Steris Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230546 — SIGNEX | Osteonic Co., Ltd. Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230069 — Mi-CHORD System | Lsi Solutions, Inc. Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241025 — JADE PLUS PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232749 — DOOPANG | Ybrain, Inc. Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |