510(k) Clearances — Page 111
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243174 — Cadence Ankle PSI System | 3D Systems, Inc. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242956 — LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle | Ocuject, LLC Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241185 — CORGRIP* SR NG/NI Tube Retention System | Avanos Medical, Inc. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242984 — BKS Revision System | Ortho Development Corp. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240269 — Nitrile Powder Free Examination Gloves Biodegradable (Green) | Comfort Rubber Gloves Industries Sdn. Bhd. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | VATECH Co., Ltd. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241007 — Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | Shenzhen Urion Technology Co., Ltd. Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242034 — Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242462 — CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242512 — ROCC Console | Philips Medical Systems Nederland B.V. Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242458 — ArgenZ MTZ | Argen Corporation Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241089 — KeyPrint KeyDenture Base | Keystone Industries Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242560 — Manual Wheelchair (SYIV100-CA9221) | Foshan Shunkangda Medical Tech Co., Ltd. Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240391 — MUTARS® femoral stem cemented 160 mm and 200 mm | Implantcast GmbH Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241554 — Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) | Telefield Medical Imaging (Shenzhen) Limited Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242086 — MagDI System (MAG-01, DS-01) | Gt Metabolic Solutions, Inc. Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240543 — Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) | Medency S.R.L. Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242589 — Scarlet® AL-T | Spineart SA Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241753 — Immediate Molar Implants | Biomet 3i, LLC Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242513 — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) | Guangdong Optomedic Technologies, Inc. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242829 — BluEX Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240289 — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) | Scivita Medical Technology Co., Ltd. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234060 — KIDNEYvault Portable Renal Perfusion System | Paragonix Technologies Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242995 — OIC Small / Mini Fragment Plate System | The Orthopaedic Implant Company Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243057 — TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241876 — Vitesse (5.0) | Varian Medical Systems Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240865 — IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241324 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242073 — STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) | Tsk Laboratory International Japan KK Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243007 — CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241988 — ProSeal Closed System Bag Access | Epic Medical Pte. , Ltd. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242847 — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); | DRTECH Corporation Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243012 — MIM Symphony HDR Fusion | Mim Software, Inc. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242183 — Fractional CO2 Laser Therapy System (EXFU CO2) | Weifang Mingliang Electronics Co., Ltd. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243209 — nordicMEDiVA | Nordicneurolab AS Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241478 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241572 — ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) | Siemens Medical Solutions USA, Inc. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242193 — Arm Type Blood Pressure Monitor (BPM82) | Avita Corporation Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) | Stryker Sustainability Solutions Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242099 — Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle | Sol-Millennium Medical, Inc. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242250 — PuraStat | 3-D Matrix Europe SAS Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | Tianjin Mastervision Technology Co., Ltd. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | Shanghai SeeGen Photoelectric Technology Co., Ltd. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240506 — KARL STORZ Holders | Karl Storz Endoscopy America, Inc. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222740 — Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch | Speciality Fibres and Materials, Ltd. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242058 — Digital Prism Correction Feature (DPCF) | Apple, Inc. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240029 — Zio AT® device (A100A1001) | iRhythm Technologies, Inc. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242157 — Anovo Surgical System (Model 6Ne) | Momentis Surgical , Ltd. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242266 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |