510(k) Clearances — Page 179
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231628 — BeShape One Device | Beshape Technologies , Ltd. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221508 — AnemoCheck Home | Sanguina, Inc. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221570 — Antibacterial bandage | Allmed Medical Products Co., Ltd. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230045 — HipCheck | Stryker Corp. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230847 — Chemotherapy Gloves | 3A Glove Sdn. Bhd. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223873 — Boppli Infant Blood Pressure Monitor | Pyrames, Inc. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231649 — Intraosseous Fusion Device System | Auxano Medical, LLC Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232299 — CeraPutty | Meta Biomed Co., Ltd. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231957 — SafeBreak® Vascular | Lineus Medical Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231622 — REGER Nebulizer Irrigation Cannula | Reger Medizintechnik, GmbH Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221900 — Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231702 — WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet | OTU Medical, Inc. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232701 — Guardenia (GAR-1) | Advanced Surgical Concepts Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN210056 — Procise IFX | Procisedx, Inc. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231527 — TriALTIS Navigation Enabled Instruments | Medos International Sàrl Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231973 — PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | Ineo Tech Sdn Bhd Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232650 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220458 — UltraFlo-R Push Button Blood Collection Set | Innovative Medical Technologies, Inc. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232647 — Microcatheter | Surmodics,Inc. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230187 — Terran NM-101 | Terran Biosciences, Inc. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232669 — TBI | Abbott Laboratories Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213403 — Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN210011 — Invitae Common Hereditary Cancers Panel | Invitae Corporation Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | Instrumentation Laboratory CO Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233257 — 3M ClarityAligners with Quick Attachments | 3M Company, Unitek Orthodontic Products Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230865 — PIVO Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. Thu Sep 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232605 — Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System | Lesspine Innovations Thu Sep 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232699 — Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. Thu Sep 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233161 — BeautiLink SA | Shofu Dental Corporation Thu Sep 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231013 — DNA/RNA Shield SafeCollect Saliva Collection kit | Zymo Research Thu Sep 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231837 — Brainomix 360 Triage LVO | Brainomix Limited Thu Sep 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231901 — Hakon, Hakon Smart | Medical San Indústria DE Equipamentos Médicos Ltda. Thu Sep 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231792 — VeriSafe Safety sterile syringes | Promisemed Hangzhou Meditech Co., Ltd. Thu Sep 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232274 — IPL hair removal device | Lumenessa Corp Thu Sep 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231188 — ALIGN Radial Head System | Skeletal Dynamics, Inc. Thu Sep 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | Abbott Diagnostics Technologies AS Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | Cepheid Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230563 — EVOLUTION® Hinge Knee System | Microport Orthopedics, Inc. Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232668 — Cove Strip, OsteoCove Strip | SeaSpine Orthopedics Corporation Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231076 — VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232260 — Thinline Sheath Introducer | Inneuroco, Inc. Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231538 — FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232596 — EndoGI S-Path Biliary Stent System | Endogi Medical, Ltd. Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232275 — Invictus® Spinal Fixation System | Alphatec Spine, Inc. Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231108 — Talon Transseptal Sheath | Inari Medical, Inc. Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232609 — Micro Ace Advanced Micro Access System | Merit Medical Systems, Inc. Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232167 — VySpan PCT System | Vy Spine, LLC Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232255 — EZSensor XHD | Qpix Solutions, Inc. Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232616 — Volta AF-Xplorer | Volta Medical Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) | Hantech Medical Device Co., Ltd. Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |