510(k) Clearances — Page 100
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242599 — aprevo® Digital Planning | Carlsmed, Inc. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241888 — Single-use Balloon Dilatation Catheter | Leo Medical Co., Ltd. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242628 — Scooter (PS30) | Lichtmega Technology Co., Ltd. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241680 — Momcozy Wearable Breast Pump (BP311) | Shenzhen Root Innovation Technology Co., Ltd. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242534 — HandPICO Fractional Laser Handpiece Tip | Vydence Medical Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240435 — Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242644 — SENDERO MAX Delivery Catheter | Okami Medical, Inc. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242923 — SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) | Envision Endoscopy Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | Andon Health Co, Ltd. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243629 — Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430) | Shenzhen Root Innovation Technology Co., , Ltd. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243675 — InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242168 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary Care Diagnostics Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243911 — HPR Cordless Hygiene Handpiece | Handpiece Headquarters Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243149 — Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | Congruence Medical Solutions, LLC Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242529 — Tigon Medical All-Suture Anchors (ASA) | Tigon Medical Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241167 — BioSphere Putty; BioSphere MIS Putty | Synergy Biomedical Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | Biofire Diagnostics, LLC Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241670 — Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | Beijing Adss Development Co., Ltd. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243607 — Moda-flx Hemodialysis System Cartridge (102121-001 ) | Diality, Inc. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241652 — DASH® SARS-CoV-2 & Flu A/B Test | Nuclein, LLC Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243040 — LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) | Shenzhen Siken 3D Technology Development Co., Ltd. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243169 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241322 — Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) | Joytech Healthcare Co. , Ltd. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242370 — Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) | Medline Industries, LP Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243071 — Bovine Dermis Collagen Dermal Matrix | Collagen Matrix, Inc. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241637 — Echo Intracranial Base Catheter | Stryker Neurovascular Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242700 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) | Shenzhen Nuon Medical Equipment Co., Ltd. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240014 — ARC-EX System | Onward Medical, Inc. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243361 — Nutrifit | Vygon USA Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243440 — Electric Wheelchair (HC820N) | Yongkang Hengyi Vehicle Co., Ltd. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243688 — Saige-Dx (3.1.0) | DeepHealth, Inc. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241168 — System 83 Revolve Endoscope Washer/Disinfector | Wassenburg Medical, Inc. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242467 — IQ-UIP | Imbio, Inc. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243171 — Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243652 — Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE) | Cardinalhealth Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232813 — Therapy EC, Therapy XT | Dmc Importacao E Exportacao DE Equipamentos Ltda Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242954 — Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243725 — BD Vaginal Panel | Becton, Dickinson and Company Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241768 — Broadway 8 Catheter | Stryker Neurovascular Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243595 — OviTex PRS (Long-Term Resorbable) | TELA Bio, Inc. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242270 — OrthoNext Platform System | Orthofix Srl Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242063 — LibAirty Airway Clearance System | Synchrony Medical , Ltd. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242908 — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | Shanghai Sigma High-Tech Co., Ltd. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242819 — IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240885 — Shadow Catheter | Simpson Interventions, Inc. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240348 — Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243705 — Saige-Density (2.5.0) | DeepHealth, Inc. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243094 — Quickdent Dental Implant System | Quickdent Devices Private , Ltd. Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241778 — Hudson RCI Comfort Flo® CubCannula | Medline Industries, LP Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |