510(k) Clearances — Page 92
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242916 — Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. Tue Feb 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250068 — Venclose digiRF Generator (VCRFG1) | Venclose, Inc. Tue Feb 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240402 — Cito CBC System | Cytochip, Inc. Mon Feb 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241590 — Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) | Guangdong Xinyu Electronic and Technology Co., Ltd. Mon Feb 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241375 — IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | Alphatec Spine Mon Feb 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241368 — Sonicaid Team3 | Huntleigh Healthcare , Ltd. Mon Feb 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243908 — Tiger 2 System | Zavation Medical Products, LLC Mon Feb 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243268 — TipTraQ (TTQ001) | Pranaq Pte. , Ltd. Mon Feb 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250035 — Contour ProtégéAI+ | Mim Software, Inc. Mon Feb 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243182 — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. Mon Feb 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243146 — iCare APP | Ihealth Labs, Inc. Mon Feb 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243393 — JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) | Shenzhen Ulike Smart Electronics Co., Ltd. Mon Feb 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241454 — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) | Guangzhou Hehong Biotech Co., Ltd. Mon Feb 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243150 — Nuance Audio Hearing Aid Software | Luxottica Group S.P.A. Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243665 — Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) | ZheJiang Decans Medical Devices Co., Ltd. Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream | Nanjing Synthgene Medical Technology Co., Ltd. Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243441 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) | Basic Medical Technology, Inc. Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 | Dornier Medtech America Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242442 — Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics, Ltd. Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | Motilitycount Aps Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter, | C.R. Bard, Inc. Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243742 — Arthrex DynaNite Nitinol Staples | Arthrex, Inc. Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242982 — Mobility Scooter (MS160A) | Suzhou Master Machinery Manufacturing Co.,Ltd Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241694 — ZeTTA PACS | Tae Young Soft Co., Ltd. Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241193 — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) | Marzzan Lucas Jorge Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243572 — Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La | Avanos Medical, Inc. Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243726 — Osprey Suture Anchor | Responsive Arthroscopy, Inc. Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243712 — WasherCap Mini Fixation System (Model 45) | Abanza Tecnomed S.L Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242757 — Rotarex Atherectomy System | Bard Peripheral Vascular, Inc. Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243442 — iBOT® PMD | Mobius Mobility Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233956 — Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | Taiwan Aulisa Medical Devices Technologies, Inc. Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243060 — TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243025 — Ureteral Access Sheath | Seplou (Zhuhai) Co., Ltd. Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241292 — MyShoulder Planner (5.3SSWPL) | Medacta International S.A. Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242568 — Wrist Blood Pressure Monitor (OHMS11, OHMS12) | Shenzhen Zhongkemingwang Telecommunications Software Corp. Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241270 — BTL-754 | BTL Industries, Inc. Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243410 — simpli-COLLECT STI Test | Abbott Molecular Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243202 — MTS Ceftobiprole 0.002-32 µg/mL | Liofilchem s.r.l. Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243673 — Xenco Medical CancelleX Cervical Interbody System | Xenco Medical, LLC Wed Jan 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243387 — GYDER® Hip System | Gyder Surgical Pty, Ltd. Wed Jan 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242217 — Surcam Dental Implant System | Surcam Medical Devices and Developments, Ltd. Wed Jan 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243740 — Versalock Upper Limb Plating System | GM Dos Reis Industria e Comercio Ltda. Wed Jan 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241915 — CareSuperb COVID-19 Antigen Home Test | Access Bio, Inc. Wed Jan 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243117 — Digital Video Processor | Hunan Vathin Medical Instrument Co., Ltd. Wed Jan 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243213 — Self-Forming Magnet (FLEX SFM) | GI Windows, Inc. Wed Jan 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243042 — Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. Wed Jan 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243501 — 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | 3M Company Tue Jan 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Brainlab AG Tue Jan 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |