510(k) Clearances — Page 198
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231153 — Neuhat Hair Growth System; ibeauty.com Laser Cap | Nature, Inc.redible, Inc. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221827 — Mais Central Venous Catheter | Saudi Mais Co. For Medical Products Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP) | Actigraph, LLC Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230276 — TECHFIT DISRP® System | Techfit Digital Surgery Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222982 — Virtus Metabolic Monitor | Virtus Technology Aps Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223013 — AccurECG Analysis System | Accurkardia, Inc. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222969 — FERTI-LILY Conception Cup | Rosesta Medical BV Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221411 — Surflo Winged Infusion Set | Terumo Medical Products (Hangzhou) Co., Ltd. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222592 — AltiVate® Anatomic Shoulder AG e+ with Markers | Encore Medical L.P. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230036 — Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | Rti Surgical, Inc. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230410 — DD medical polymers (PMMA) | Dental Direkt GmbH Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231185 — MapRT | Vision Rt, Ltd. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223159 — Radixact Treatment Delivery System | Accuray Incorporated Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220955 — Hudson RCI Variable concentration Large Volume Nebulizer (1770) | Medline Industires, Inc. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230359 — KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- | Karl Storz Endoscopy America, Inc. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement | Spineart Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230444 — Talee, Talee PostOp | Invent Medical USA, LLC Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230322 — SelectFlex Neurovascular Access System Family | Q'Apel Medical, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223741 — Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) | Zhuhai Pusen Medical Technology Co., Ltd. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223558 — CUVIS-spine | Curexo, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230904 — Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231202 — QuickRayPRO | Denterprise International, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230497 — Bladder AI (AIBV01) | Exo, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222932 — INVOcell Intravaginal Culture System | Invo Bioscience Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223083 — Straumann SLActive labeling changes | Institut Straumann AG Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231131 — Diode Laser Body Sculpture Systems | Shanghai Bele Medical Technology Co.,Ltd Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223871 — Miria Skin Treatment System | AVAVA, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223379 — Portable Oxygen Concentrator (Model: P2-E7, P2-E) | Qingdao Kingon Medical Science and Technology Co., Ltd. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230599 — TargetCool | Recensmedical, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230309 — Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) | Centerline Biomedical, Inc. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230886 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221311 — Antibacterial Bandage | Winner Medical Co., Ltd. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) | Cardinal Health200, LLC Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231467 — 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Rayence Co., Ltd. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223248 — Tablo® Hemodialysis System | Outset Medical, Inc. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231031 — ACL TOP Family 70 Series | Instrumentation Laboratory Company Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231212 — da Vinci E-200 Electrosurgical Generator | Intuitive Surgical Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231469 — PAXgene® Blood DNA Tube | Preanalytix GmbH Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222658 — Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223033 — Tixel® 2 System | Novoxel , Ltd. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231485 — iLet® ACE Pump | Beta Bionics, Inc. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230506 — PureLift Pro Edition | Xtreem Pulse Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231489 — Sturdy Autoclave Super Microm | Sturdy Industrial Co., Ltd. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231533 — Habib EndoHPB | Boston Scientific Corporation Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | Carl Zeiss Meditec, Inc. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223522 — NC° Thermometer (Gen 3), Model Number: NCTG3 | Xiamen Intretech, Inc. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230993 — CODA Anterior Cervical Plate System | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223029 — Perfit CL | Vatech Mcis Co., Ltd. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222998 — F3 | Acrew Imaging, Inc. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223535 — SMARTbase Abutment System | Implant Direct Sybron Manufacturing, LLC Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |